<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/NCT03788434</url>
  </required_header>
  <id_info>
    <org_study_id>CONSORTIUM (VE303-002)</org_study_id>
    <nct_id>NCT03788434</nct_id>
  </id_info>
  <brief_title>Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection</brief_title>
  <acronym>CONSORTIUM</acronym>
  <official_title>CONSORTIUM - A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vedanta Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vedanta Biosciences, 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 study evaluated the safety and efficacy of VE303 for participants with primary C.&#xD;
      difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C.&#xD;
      difficile infections (rCDI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CONSORTIUM was a randomized, placebo-controlled double-blind Phase 2 study to evaluate&#xD;
      safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of VE303 in prevention&#xD;
      of subsequent Clostridioides difficile infection (CDI) -associated diarrhea compared with&#xD;
      placebo following completion of at least 1 successful course of standard-of-care (SOC)&#xD;
      antibiotics. VE303 or placebo capsules were taken orally for 14 days after completion of a&#xD;
      course of SOC antibiotics. The proportions of subjects experiencing a confirmed CDI&#xD;
      recurrence within 8 weeks after the first dose of study treatment were compared across the&#xD;
      study arms, to understand the efficacy of VE303 in preventing rCDI.&#xD;
&#xD;
      The study originally planned to enroll 146 subjects but through a protocol amendment was&#xD;
      revised to an enrollment target of 60 to 80 subjects with a prior history of CDI diarrhea or&#xD;
      first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must have had a&#xD;
      positive C. difficile stool sample and have responded to SOC antibiotic treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">September 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 2, 2021</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>This Phase 2 study evaluated the safety and efficacy of the study drug, VE303, at preventing subsequent CDI-associated diarrhea compared with placebo, following completion of at least 1 successful course of SOC antibiotics for subjects with pCDI at high risk for recurrence or subjects with rCDI.&#xD;
Participants in the study were randomized into 3 arms in a 1:1:1 ratio of high dose VE303, low dose VE303, and placebo.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>To reduce potential bias and increase study data integrity, study participants, care providers, site investigators, and study outcomes assessors were masked to study treatment assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CDI Recurrence Week 8</measure>
    <time_frame>8 weeks</time_frame>
    <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VE303 Strains Detected</measure>
    <time_frame>24 weeks</time_frame>
    <description>Characterize the number of VE303 strains detected in the fecal microbiome at week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VE303 Relative Abundance</measure>
    <time_frame>24 weeks</time_frame>
    <description>Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>CDI Recurrence Week 4</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment).</description>
  </other_outcome>
  <other_outcome>
    <measure>CDI Recurrence Week 12</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment).</description>
  </other_outcome>
  <other_outcome>
    <measure>CDI Recurrence Week 24</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).</description>
  </other_outcome>
  <other_outcome>
    <measure>Microbiota Diversity</measure>
    <time_frame>24 weeks</time_frame>
    <description>Characterize the fecal microbiome Shannon Diversity at week 24.</description>
  </other_outcome>
  <other_outcome>
    <measure>Determine the Recommended VE303 Phase 3 Dose Regimen(s).</measure>
    <time_frame>31 Months 1 Week</time_frame>
    <description>Determine the recommended VE303 phase 3 dose regimen(s) based on safety and efficacy, as indicated by the CDI recurrence rate for the duration of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in the Fecal Metabolomic Profile, Including Short-chain Fatty Acids and Bile Acids.</measure>
    <time_frame>31 Months 1 Week</time_frame>
    <description>Changes in the fecal metabolomic profile, including short-chain fatty acids and bile acids for the duration of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Taxonomic Composition</measure>
    <time_frame>31 Months, 1 Week</time_frame>
    <description>Characterize Taxonomic Composition</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Clostridium Difficile Infection Recurrence</condition>
  <condition>Clostridium Difficile Infection</condition>
  <condition>Clostridium Difficile</condition>
  <condition>Clostridioides Difficile Infection Recurrence</condition>
  <condition>Clostridioides Difficile Infection</condition>
  <condition>Clostridioides Difficile</condition>
  <condition>CDI</condition>
  <arm_group>
    <arm_group_label>VE303 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects assigned the high dose VE303 arm took 10 capsules (dosage: 8.0 × 10^9 CFU daily) containing VE303 per day for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VE303 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects assigned to the low dose VE303 arm took 2 capsules (dosage: 1.6 × 10^9 CFU daily) containing VE303 per day for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VE303</intervention_name>
    <description>VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions.</description>
    <arm_group_label>VE303 High Dose</arm_group_label>
    <arm_group_label>VE303 Low Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Partial Inclusion Criteria:&#xD;
&#xD;
          1. Able and willing to provide written informed consent&#xD;
&#xD;
          2. Subjects with a qualifying CDI episode who had a prior history of CDI diarrhea (≥ 18&#xD;
             years of age) or first occurrence of CDI diarrhea with a higher risk for recurrence (≥&#xD;
             75 years of age, or ≥ 65 years of age with one or more prespecified conditions)&#xD;
&#xD;
          3. CDI symptoms must have started within 30 days (inclusive) prior to the day of&#xD;
             randomization&#xD;
&#xD;
          4. The diarrhea was considered unlikely to have another etiology.&#xD;
&#xD;
          5. Completed an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and&#xD;
             up to 21 days of total duration&#xD;
&#xD;
          6. Have a positive C. difficile stool&#xD;
&#xD;
          7. Recovered from any complications of severe or fulminant CDI and clinically stable by&#xD;
             the time of randomization.&#xD;
&#xD;
        Partial Exclusion Criteria:&#xD;
&#xD;
          1. History of diarrhea (defined as 3 or more loose stools per day lasting for at least 4&#xD;
             weeks) that was not related to C. difficile infection within the 3 months prior to&#xD;
             randomization.&#xD;
&#xD;
          2. Known or suspected toxic megacolon and/or known small bowel ileus at the time of&#xD;
             randomization.&#xD;
&#xD;
          3. Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting,&#xD;
             or ileus).&#xD;
&#xD;
          4. Prior administration of genetically modified investigational live&#xD;
             bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea&#xD;
&#xD;
          5. History of administration of fecally-derived investigational live biotherapeutic&#xD;
             products, or fecally-derived live bacterial isolates for CDI-associated diarrhea&#xD;
             including fecal microbiota transplantation (FMT) within the last 6 months.&#xD;
&#xD;
          6. Use of drugs that alter gut motility&#xD;
&#xD;
          7. History of acute leukemia or hematopoietic stem cell transplantation or&#xD;
             myelosuppressive chemotherapy within 2 months prior to randomization.&#xD;
&#xD;
          8. Subjects with compromised immune system&#xD;
&#xD;
          9. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within&#xD;
             3 months prior to randomization or any history of total colectomy or bariatric surgery&#xD;
             that disrupts the gastrointestinal lumen.&#xD;
&#xD;
         10. History of confirmed celiac disease, inflammatory bowel disease, short gut,&#xD;
             gastrointestinal tract fistulas, or ischemia.&#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>Darrell Pardi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Clinical, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic, Clinical Studies Unit</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEA Baptist Clinic</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Institute</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ventura Clinical Trials</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Center of Connecticut, LLC</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Research of West Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guardian Angel Research Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anne Arundel Health System Research Insitute</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covenant HealthCare</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Gastonia</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Research Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Institute of Clinical Research Inc</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TruCare Internal Medicine and Infectious Diseases</name>
      <address>
        <city>DuBois</city>
        <state>Pennsylvania</state>
        <zip>15801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frontier Clinical Research, LLC</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research-Be Well MD</name>
      <address>
        <city>Cedar Park</city>
        <state>Texas</state>
        <zip>78613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Centers for Infectious Disease Associates</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinrx Research Joseph INC</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Disease Associates of Central Virginia Infectious Disease</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Infectious Disease Clinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research-Spokane Gastroenterology</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre - Microbial Health Clinic</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CARe Clinic</name>
      <address>
        <city>Red Deer</city>
        <state>Alberta</state>
        <zip>T4N6V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moncton Hospital</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C6Z8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viable Clinical Research</name>
      <address>
        <city>Scarborough</city>
        <state>Ontario</state>
        <zip>M1P2T7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q&amp;T Research Chicoutimi</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H7Y8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Québec-Université Laval</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <zip>G8Z3R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <results_first_submitted>August 29, 2022</results_first_submitted>
  <results_first_submitted_qc>June 29, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clostridium Difficile Infection Recurrence</keyword>
  <keyword>Clostridium Difficile Infection</keyword>
  <keyword>Clostridium Difficile</keyword>
  <keyword>VE303</keyword>
  <keyword>Consortium</keyword>
  <keyword>Vedanta</keyword>
  <keyword>CDI</keyword>
  <keyword>C. Diff</keyword>
  <keyword>CDiff</keyword>
  <keyword>Clostridiodes Difficile Infection Recurrence</keyword>
  <keyword>Clostridiodes Difficile Infection</keyword>
  <keyword>Clostridioides Difficile</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>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>July 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03788434/Prot_002.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>July 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03788434/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VE303 High Dose</title>
          <description>Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
        </group>
        <group group_id="P2">
          <title>VE303 Low Dose</title>
          <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VE303 High Dose</title>
          <description>Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
        </group>
        <group group_id="B2">
          <title>VE303 Low Dose</title>
          <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
        </group>
        <group group_id="B4">
          <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="30"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="22"/>
            <count group_id="B4" value="79"/>
          </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="39"/>
                  </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="62.3" spread="14.99"/>
                    <measurement group_id="B2" value="62.9" spread="17.85"/>
                    <measurement group_id="B3" value="60.8" spread="15.98"/>
                    <measurement group_id="B4" value="62.1" spread="16.12"/>
                  </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="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="23"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>CDI Recurrence Week 8</title>
        <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VE303 High Dose</title>
            <description>Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O2">
            <title>VE303 Low Dose</title>
            <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
          </group>
        </group_list>
        <measure>
          <title>CDI Recurrence Week 8</title>
          <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C. difficile recurrences (toxin-positive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VE303 Strains Detected</title>
        <description>Characterize the number of VE303 strains detected in the fecal microbiome at week 24.</description>
        <time_frame>24 weeks</time_frame>
        <population>Enrolled subjects who provided stool samples for analysis at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>VE303 High Dose</title>
            <description>Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O2">
            <title>VE303 Low Dose</title>
            <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
          </group>
        </group_list>
        <measure>
          <title>VE303 Strains Detected</title>
          <description>Characterize the number of VE303 strains detected in the fecal microbiome at week 24.</description>
          <population>Enrolled subjects who provided stool samples for analysis at week 24.</population>
          <units>Number of VE303 strains detected</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" spread="2.807"/>
                    <measurement group_id="O2" value="1.62" spread="1.962"/>
                    <measurement group_id="O3" value="0.36" spread="0.633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VE303 Relative Abundance</title>
        <description>Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.</description>
        <time_frame>24 weeks</time_frame>
        <population>Enrolled subjects who provided stool samples for analysis at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>VE303 High Dose</title>
            <description>Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O2">
            <title>VE303 Low Dose</title>
            <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
          </group>
        </group_list>
        <measure>
          <title>VE303 Relative Abundance</title>
          <description>Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.</description>
          <population>Enrolled subjects who provided stool samples for analysis at week 24.</population>
          <units>Proportion of VE303 strains</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01186" spread="0.013897"/>
                    <measurement group_id="O2" value="0.00775" spread="0.016007"/>
                    <measurement group_id="O3" value="0.00097" spread="0.002297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CDI Recurrence Week 4</title>
        <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment).</description>
        <time_frame>4 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VE303 High Dose</title>
            <description>Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O2">
            <title>VE303 Low Dose</title>
            <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
          </group>
        </group_list>
        <measure>
          <title>CDI Recurrence Week 4</title>
          <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C. difficile recurrences (toxin-positive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CDI Recurrence Week 12</title>
        <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment).</description>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VE303 High Dose</title>
            <description>Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O2">
            <title>VE303 Low Dose</title>
            <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
          </group>
        </group_list>
        <measure>
          <title>CDI Recurrence Week 12</title>
          <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C. difficile recurrences (toxin-positive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CDI Recurrence Week 24</title>
        <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).</description>
        <time_frame>24 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VE303 High Dose</title>
            <description>Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O2">
            <title>VE303 Low Dose</title>
            <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
          </group>
        </group_list>
        <measure>
          <title>CDI Recurrence Week 24</title>
          <description>Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C. difficile recurrences (toxin-positive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Microbiota Diversity</title>
        <description>Characterize the fecal microbiome Shannon Diversity at week 24.</description>
        <time_frame>24 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Determine the Recommended VE303 Phase 3 Dose Regimen(s).</title>
        <description>Determine the recommended VE303 phase 3 dose regimen(s) based on safety and efficacy, as indicated by the CDI recurrence rate for the duration of the study.</description>
        <time_frame>31 Months 1 Week</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in the Fecal Metabolomic Profile, Including Short-chain Fatty Acids and Bile Acids.</title>
        <description>Changes in the fecal metabolomic profile, including short-chain fatty acids and bile acids for the duration of the study.</description>
        <time_frame>31 Months 1 Week</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Taxonomic Composition</title>
        <description>Characterize Taxonomic Composition</description>
        <time_frame>31 Months, 1 Week</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>VE303 High Dose</title>
          <description>Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
        </group>
        <group group_id="E2">
          <title>VE303 Low Dose</title>
          <description>Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.&#xD;
VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.&#xD;
Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CDI</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Escherichia Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Transfusion Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="28" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="243" subjects_affected="21" subjects_at_risk="29"/>
                <counts group_id="E2" events="213" subjects_affected="23" subjects_at_risk="27"/>
                <counts group_id="E3" events="114" subjects_affected="19" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Irritable Bowel Syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Potassium Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jeffrey Silber</name_or_title>
      <organization>Vedanta Biosciences</organization>
      <phone>(857) 706-1427</phone>
      <email>ConsortiumIO-ctinquiries@vedantabio.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/NCT03788434
org study id: CONSORTIUM (VE303-002)
nct id: NCT03788434
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluated the safety and efficacy of VE303 for participants with primary C.
      difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C.
      difficile infections (rCDI).
CONSORTIUM was a randomized, placebo-controlled double-blind Phase 2 study to evaluate
      safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of VE303 in prevention
      of subsequent Clostridioides difficile infection (CDI) -associated diarrhea compared with
      placebo following completion of at least 1 successful course of standard-of-care (SOC)
      antibiotics. VE303 or placebo capsules were taken orally for 14 days after completion of a
      course of SOC antibiotics. The proportions of subjects experiencing a confirmed CDI
      recurrence within 8 weeks after the first dose of study treatment were compared across the
      study arms, to understand the efficacy of VE303 in preventing rCDI.

      The study originally planned to enroll 146 subjects but through a protocol amendment was
      revised to an enrollment target of 60 to 80 subjects with a prior history of CDI diarrhea or
      first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must have had a
      positive C. difficile stool sample and have responded to SOC antibiotic treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This Phase 2 study evaluated the safety and efficacy of the study drug, VE303, at preventing subsequent CDI-associated diarrhea compared with placebo, following completion of at least 1 successful course of SOC antibiotics for subjects with pCDI at high risk for recurrence or subjects with rCDI.
Participants in the study were randomized into 3 arms in a 1:1:1 ratio of high dose VE303, low dose VE303, and placebo.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: To reduce potential bias and increase study data integrity, study participants, care providers, site investigators, and study outcomes assessors were masked to study treatment assignment.
measure: CDI Recurrence Week 8
time frame: 8 weeks
description: Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).
measure: VE303 Strains Detected
time frame: 24 weeks
description: Characterize the number of VE303 strains detected in the fecal microbiome at week 24.
measure: VE303 Relative Abundance
time frame: 24 weeks
description: Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.
measure: CDI Recurrence Week 4
time frame: 4 Weeks
description: Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment).
measure: CDI Recurrence Week 12
time frame: 12 Weeks
description: Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment).
measure: CDI Recurrence Week 24
time frame: 24 Weeks
description: Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).
measure: Microbiota Diversity
time frame: 24 weeks
description: Characterize the fecal microbiome Shannon Diversity at week 24.
measure: Determine the Recommended VE303 Phase 3 Dose Regimen(s).
time frame: 31 Months 1 Week
description: Determine the recommended VE303 phase 3 dose regimen(s) based on safety and efficacy, as indicated by the CDI recurrence rate for the duration of the study.
measure: Changes in the Fecal Metabolomic Profile, Including Short-chain Fatty Acids and Bile Acids.
time frame: 31 Months 1 Week
description: Changes in the fecal metabolomic profile, including short-chain fatty acids and bile acids for the duration of the study.
measure: Taxonomic Composition
time frame: 31 Months, 1 Week
description: Characterize Taxonomic Composition
arm group label: VE303 High Dose
arm group type: Experimental
description: Study subjects assigned the high dose VE303 arm took 10 capsules (dosage: 8.0 × 10^9 CFU daily) containing VE303 per day for 14 days.
arm group label: VE303 Low Dose
arm group type: Experimental
description: Study subjects assigned to the low dose VE303 arm took 2 capsules (dosage: 1.6 × 10^9 CFU daily) containing VE303 per day for 14 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.
intervention type: Drug
intervention name: VE303
description: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions.
arm group label: VE303 High Dose
arm group label: VE303 Low Dose
intervention type: Drug
intervention name: Placebo
description: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Darrell Pardi, MD
role: Principal Investigator
affiliation: Mayo Clinic
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
mesh term: Recurrence
sharing ipd: No
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