<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03244644</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01</org_study_id>
    <nct_id>NCT03244644</nct_id>
  </id_info>
  <brief_title>Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)</brief_title>
  <official_title>A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rebiotix Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rebiotix Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3&#xD;
      study of a microbiota suspension of intestinal microbes. Patients who have had at least one&#xD;
      recurrence after a primary episode and have completed at least one round of standard-of-care&#xD;
      oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile&#xD;
      infection (CDI) resulting in hospitalization within the last year may be eligible for the&#xD;
      study. Subjects who are deemed failures following the blinded treatment per the pre-specified&#xD;
      treatment failure definition may elect to receive an unblinded dose of RBX2660.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3&#xD;
      study of a microbiota suspension of intestinal microbes. The primary assessments for this&#xD;
      study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes&#xD;
      of CDI and (ii) safety via assessment of adverse events. The primary efficacy analysis of the&#xD;
      study will be a Bayesian hierarchical model, which formally incorporates data from a previous&#xD;
      randomized Phase 2b study (Protocol 2014-01, NCT02299570) of RBX2660.&#xD;
&#xD;
      Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study&#xD;
      treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the&#xD;
      study treatment and at months 3 and 6. Patients who have had at least one recurrence after a&#xD;
      primary episode and have completed at least one round of standard-of-care oral antibiotic&#xD;
      therapy or have had at least two episodes of severe CDI resulting in hospitalization within&#xD;
      the last year may be eligible for the study. Study Subjects who are deemed failures following&#xD;
      the blinded treatment per the pre-specified treatment failure definition may elect to receive&#xD;
      an unblinded dose of RBX2660.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">August 3, 2020</completion_date>
  <primary_completion_date type="Actual">April 2, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of RBX2660 Compared to Placebo Through 8 Weeks</measure>
    <time_frame>8 weeks after completing the study treatment</time_frame>
    <description>The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained Clinical Response Through 6 Months After Blinded Treatment</measure>
    <time_frame>6 months after completing the study treatment</time_frame>
    <description>The rates of Sustained Clinical Response (i.e., the occurrence of new CDI infections from baseline through 6 months) was assessed by either the rate of new CDI infections after treatment success at 8 weeks (durability) or the frequency of total CDI infections from baseline through 6 months.&#xD;
Sustained Clinical Response was compared between the RBX2660 group and the control group using a chi-square test. Patients who exited prior to their 6-month follow-up were conservatively counted as a Treatment Failure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Clostridium Difficile Infection (CDI)</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is an suspension of normal saline. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RBX2660</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation United States Pharmacopeia (USP) solution and cryoprotectant</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBX2660</intervention_name>
    <description>RBX2660 is a rectally administered microbiota suspension</description>
    <arm_group_label>RBX2660</arm_group_label>
    <other_name>microbiota suspension</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is normal saline solution administered rectally</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Open label RBX2660 (only for confirmed CDI recurrence)</intervention_name>
    <description>RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>RBX2660</arm_group_label>
    <other_name>microbiota suspension</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years old.&#xD;
&#xD;
          2. Medical record documentation of recurrent CDI per the study definition, that includes&#xD;
             either: a) at least one recurrence after a primary episode and has completed at least&#xD;
             one round of standard-of-care oral antibiotic therapy or b) has had at least two&#xD;
             episodes of severe CDI resulting in hospitalization within the last year.&#xD;
&#xD;
          3. A positive stool test for the presence of toxigenic C. difficile within 30 days prior&#xD;
             to or on the date of enrollment.&#xD;
&#xD;
          4. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea&#xD;
             at the time of enrollment.&#xD;
&#xD;
        [Note: Subject's CDI diarrhea must be controlled (&lt;3 unformed/loose stools/day) while&#xD;
        taking this course of antibiotics]&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI&#xD;
             treatment.&#xD;
&#xD;
          2. Previous fecal transplant&#xD;
&#xD;
          3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's&#xD;
             disease, or microscopic colitis.&#xD;
&#xD;
          4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.&#xD;
&#xD;
          5. Compromised immune system (e.g. immunosuppressed due to a medical condition or&#xD;
             medication; current or recent (&lt; 90 days) treatment with chemotherapy)&#xD;
&#xD;
          6. An absolute neutrophil count of &lt;1000 cells/µL during screening.&#xD;
&#xD;
          7. Pregnant, breastfeeding, or intends to become pregnant during study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teena Chopra, M.D., M.P.H.</last_name>
    <role>Study Chair</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Athens</name>
      <address>
        <city>Athens</city>
        <state>Alabama</state>
        <zip>35611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dothan</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Little Rock</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancaster</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxnard</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamden</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Port Orange</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Falls</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gurnee</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highland Park</name>
      <address>
        <city>Highland Park</city>
        <state>Illinois</state>
        <zip>60035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maywood</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lafayette</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Topeka</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexington</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detroit</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-4031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teaneck</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Massapequa</name>
      <address>
        <city>North Massapequa</city>
        <state>New York</state>
        <zip>11758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmington</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fargo</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portland</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flourtown</name>
      <address>
        <city>Flourtown</city>
        <state>Pennsylvania</state>
        <zip>19031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107-5244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniontown</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wyomissing</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid City</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hixson</name>
      <address>
        <city>Hixson</city>
        <state>Tennessee</state>
        <zip>37434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Jordan</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Virginia</state>
        <zip>22150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winchester</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edmonton</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>TG2X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver</name>
      <address>
        <city>Vancouver</city>
        <state>British Columba</state>
        <zip>V5Z1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>BC V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fredericton</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 4R3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moncton</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C628</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.cdc.gov/hai/eip/cdiff-tracking.html</url>
    <description>Centers for Disease Control page last reviewed March 15, 2021; accessed March 01, 2022.</description>
  </link>
  <link>
    <url>http://www.rebiotix.com</url>
    <description>Sponsor website</description>
  </link>
  <link>
    <url>https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-22-2022-meeting-announcement</url>
    <description>Rebyota sponsor briefing book</description>
  </link>
  <reference>
    <citation>Bakken JS. Feces transplantation for recurrent Clostridium difficile infection: US experience and recommendations. Microb Ecol Health Dis. 2015 May 29;26:27657. doi: 10.3402/mehd.v26.27657. eCollection 2015. No abstract available.</citation>
    <PMID>26031677</PMID>
  </reference>
  <reference>
    <citation>EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available.</citation>
    <PMID>13592638</PMID>
  </reference>
  <reference>
    <citation>Miller MA, Louie T, Mullane K, Weiss K, Lentnek A, Golan Y, Kean Y, Sears P. Derivation and validation of a simple clinical bedside score (ATLAS) for Clostridium difficile infection which predicts response to therapy. BMC Infect Dis. 2013 Mar 25;13:148. doi: 10.1186/1471-2334-13-148.</citation>
    <PMID>23530807</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <results_first_submitted>June 9, 2023</results_first_submitted>
  <results_first_submitted_qc>August 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 14, 2023</results_first_posted>
  <disposition_first_submitted>March 29, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>August 10, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 14, 2023</disposition_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>C Difficile Colitis</keyword>
  <keyword>Clostridium Difficile</keyword>
  <keyword>CDI</keyword>
  <keyword>C.Difficile Diarrhea</keyword>
  <keyword>Fecal Transplant</keyword>
  <keyword>Fecal Microbiota Transplant (FMT)</keyword>
  <keyword>Microbiota Restoration Therapy</keyword>
  <keyword>Diarrhea</keyword>
  <keyword>FMT</keyword>
  <keyword>Microbial Suspension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Clostridium Infections</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03244644/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03244644/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment was from July 2017 to February 2020 at 44 medical clinics in the United States and Canada. Recruitment was performed by trained investigators and study coordinators.</recruitment_details>
      <pre_assignment_details>A total of 320 subjects were enrolled (signed consent) of which 31 were screen failures.&#xD;
289 subjects were randomized: 193 to RBX2660 and 96 to placebo. Of the 289, 22 did not receive the allocated treatment.&#xD;
Therefore, a total of 267 subjects were randomized and treated: 180 subjects were treated with blinded RBX2660 treatment and 87 subjects were treated with blinded Placebo treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding&#xD;
Placebo: Placebo is normal saline solution administered rectally</description>
        </group>
        <group group_id="P2">
          <title>RBX2660</title>
          <description>RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation United States Pharmacopeia (USP) solution and cryoprotectant&#xD;
RBX2660: RBX2660 is a microbiota suspension administered rectally</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="180"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding&#xD;
Placebo: Placebo is normal saline solution administered rectally</description>
        </group>
        <group group_id="B2">
          <title>RBX2660</title>
          <description>RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant&#xD;
RBX2660: RBX2660 is a microbiota suspension administered rectally</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="87"/>
            <count group_id="B2" value="180"/>
            <count group_id="B3" value="267"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.7" spread="15.95"/>
                    <measurement group_id="B2" value="61.3" spread="16.81"/>
                    <measurement group_id="B3" value="60.1" spread="16.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.0" lower_limit="26" upper_limit="86"/>
                    <measurement group_id="B2" value="64.0" lower_limit="19" upper_limit="93"/>
                    <measurement group_id="B3" value="63.0" lower_limit="19" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="248"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="246"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clostridioides difficile infection (CDI) History</title>
          <description>Number of CDI Episodes before Blinded Treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antibiotic Screening</title>
          <description>Antibiotics taken for qualifying CDI event prior to Blinded Treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Vancomycin alone</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vancomycin in combination</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fidaxomicin</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of RBX2660 Compared to Placebo Through 8 Weeks</title>
        <description>The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.</description>
        <time_frame>8 weeks after completing the study treatment</time_frame>
        <population>The modified Intent-To-Treat (mITT) Population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding&#xD;
Placebo: Placebo is normal saline solution administered rectally</description>
          </group>
          <group group_id="O2">
            <title>RBX2660</title>
            <description>RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant&#xD;
RBX2660: RBX2660 is a microbiota suspension administered rectally</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of RBX2660 Compared to Placebo Through 8 Weeks</title>
          <description>The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.</description>
          <population>The modified Intent-To-Treat (mITT) Population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.</population>
          <units>Model-estimated percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5" lower_limit="48.1" upper_limit="67.1"/>
                    <measurement group_id="O2" value="70.6" lower_limit="64.1" upper_limit="76.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A hierarchical, closed-testing procedure (Bayesian hierarchical model) was utilized for the primary endpoint. The Bayesian hierarchical model formally incorporated data from the previous Phase 2B study (NCT02299570) of RBX2660. This analysis tested the hypothesis that the response rate of RBX2660 was superior to Placebo and was performed at the nominal 0.00125 and 0.025 one-sided levels.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Treatment Difference</param_type>
            <param_value>13.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.3</ci_lower_limit>
            <ci_upper_limit>24.0</ci_upper_limit>
            <estimate_desc>The Bayesian posterior probability of superiority was 0.99136. This value exceeded the pre-specified threshold of 0.9750338 (nominal 0.025 one-sided level).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sustained Clinical Response Through 6 Months After Blinded Treatment</title>
        <description>The rates of Sustained Clinical Response (i.e., the occurrence of new CDI infections from baseline through 6 months) was assessed by either the rate of new CDI infections after treatment success at 8 weeks (durability) or the frequency of total CDI infections from baseline through 6 months.&#xD;
Sustained Clinical Response was compared between the RBX2660 group and the control group using a chi-square test. Patients who exited prior to their 6-month follow-up were conservatively counted as a Treatment Failure</description>
        <time_frame>6 months after completing the study treatment</time_frame>
        <population>The mITT population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding&#xD;
Placebo: Placebo is normal saline solution administered rectally</description>
          </group>
          <group group_id="O2">
            <title>RBX2660</title>
            <description>RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant&#xD;
RBX2660: RBX2660 is a microbiota suspension administered rectally</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Clinical Response Through 6 Months After Blinded Treatment</title>
          <description>The rates of Sustained Clinical Response (i.e., the occurrence of new CDI infections from baseline through 6 months) was assessed by either the rate of new CDI infections after treatment success at 8 weeks (durability) or the frequency of total CDI infections from baseline through 6 months.&#xD;
Sustained Clinical Response was compared between the RBX2660 group and the control group using a chi-square test. Patients who exited prior to their 6-month follow-up were conservatively counted as a Treatment Failure</description>
          <population>The mITT population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>From 8 weeks through 6 months (Durability)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Through 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.156</p_value>
            <p_value_desc>P-value for secondary outcome evaluated from baseline through 6 months</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660.</time_frame>
      <desc>Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Only</title>
          <description>Placebo randomized subjects who did not receive an unblinded RBX2660.&#xD;
Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding&#xD;
Placebo: Placebo is normal saline solution administered rectally</description>
        </group>
        <group group_id="E2">
          <title>RBX2660 Only</title>
          <description>RBX2660 randomized subjects who did not receive an unblinded RBX2660.&#xD;
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant&#xD;
RBX2660: RBX2660 is a microbiota suspension administered rectally</description>
        </group>
        <group group_id="E3">
          <title>Blinded Placebo/Open-label RBX2660 (Blinded Period)</title>
          <description>Placebo randomized subjects who went on to receive an unblinded RBX2660 (blinded period).&#xD;
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.&#xD;
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.&#xD;
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant</description>
        </group>
        <group group_id="E4">
          <title>Blinded RBX2660/Open-label RBX2660 (Blinded Period)</title>
          <description>RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (blinded period).&#xD;
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.&#xD;
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.&#xD;
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant</description>
        </group>
        <group group_id="E5">
          <title>Blinded Placebo/Open-label RBX2660 (Open-label Period)</title>
          <description>Placebo randomized subjects who went on to receive an unblinded RBX2660 (open-label period).&#xD;
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.&#xD;
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.&#xD;
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant</description>
        </group>
        <group group_id="E6">
          <title>Blinded RBX2660/Open-label RBX2660 (Open-label Period)</title>
          <description>RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (open-label period).&#xD;
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe.&#xD;
Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding.&#xD;
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Gastritis alcoholic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Multimorbidity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="139"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="63"/>
                <counts group_id="E2" events="40" subjects_affected="28" subjects_at_risk="139"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E6" events="12" subjects_affected="9" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="8" subjects_affected="6" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Development</name_or_title>
      <organization>Rebiotix inc, a Ferring Company</organization>
      <phone>651-705-8778</phone>
      <email>US8-StudyInfo@ferring.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03244644
org study id: 2017-01
nct id: NCT03244644
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3
      study of a microbiota suspension of intestinal microbes. Patients who have had at least one
      recurrence after a primary episode and have completed at least one round of standard-of-care
      oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile
      infection (CDI) resulting in hospitalization within the last year may be eligible for the
      study. Subjects who are deemed failures following the blinded treatment per the pre-specified
      treatment failure definition may elect to receive an unblinded dose of RBX2660.
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3
      study of a microbiota suspension of intestinal microbes. The primary assessments for this
      study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes
      of CDI and (ii) safety via assessment of adverse events. The primary efficacy analysis of the
      study will be a Bayesian hierarchical model, which formally incorporates data from a previous
      randomized Phase 2b study (Protocol 2014-01, NCT02299570) of RBX2660.

      Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study
      treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the
      study treatment and at months 3 and 6. Patients who have had at least one recurrence after a
      primary episode and have completed at least one round of standard-of-care oral antibiotic
      therapy or have had at least two episodes of severe CDI resulting in hospitalization within
      the last year may be eligible for the study. Study Subjects who are deemed failures following
      the blinded treatment per the pre-specified treatment failure definition may elect to receive
      an unblinded dose of RBX2660.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Efficacy of RBX2660 Compared to Placebo Through 8 Weeks
time frame: 8 weeks after completing the study treatment
description: The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.
measure: Sustained Clinical Response Through 6 Months After Blinded Treatment
time frame: 6 months after completing the study treatment
description: The rates of Sustained Clinical Response (i.e., the occurrence of new CDI infections from baseline through 6 months) was assessed by either the rate of new CDI infections after treatment success at 8 weeks (durability) or the frequency of total CDI infections from baseline through 6 months.
Sustained Clinical Response was compared between the RBX2660 group and the control group using a chi-square test. Patients who exited prior to their 6-month follow-up were conservatively counted as a Treatment Failure
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo is an suspension of normal saline. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
arm group label: RBX2660
arm group type: Experimental
description: RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation United States Pharmacopeia (USP) solution and cryoprotectant
intervention type: Drug
intervention name: RBX2660
description: RBX2660 is a rectally administered microbiota suspension
arm group label: RBX2660
other name: microbiota suspension
intervention type: Drug
intervention name: Placebo
description: Placebo is normal saline solution administered rectally
arm group label: Placebo
other name: saline solution
intervention type: Drug
intervention name: Open label RBX2660 (only for confirmed CDI recurrence)
description: RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660
arm group label: Placebo
arm group label: RBX2660
other name: microbiota suspension
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Teena Chopra, M.D., M.P.H.
role: Study Chair
affiliation: Wayne State University
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country: Canada
country: United States
url: https://www.cdc.gov/hai/eip/cdiff-tracking.html
description: Centers for Disease Control page last reviewed March 15, 2021; accessed March 01, 2022.
url: http://www.rebiotix.com
description: Sponsor website
url: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-22-2022-meeting-announcement
description: Rebyota sponsor briefing book
citation: Bakken JS. Feces transplantation for recurrent Clostridium difficile infection: US experience and recommendations. Microb Ecol Health Dis. 2015 May 29;26:27657. doi: 10.3402/mehd.v26.27657. eCollection 2015. No abstract available.
PMID: 26031677
citation: EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available.
PMID: 13592638
citation: Miller MA, Louie T, Mullane K, Weiss K, Lentnek A, Golan Y, Kean Y, Sears P. Derivation and validation of a simple clinical bedside score (ATLAS) for Clostridium difficile infection which predicts response to therapy. BMC Infect Dis. 2013 Mar 25;13:148. doi: 10.1186/1471-2334-13-148.
PMID: 23530807
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
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