<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/NCT02981316</url>
  </required_header>
  <id_info>
    <org_study_id>15-008828</org_study_id>
    <nct_id>NCT02981316</nct_id>
  </id_info>
  <brief_title>Treatment of Recurrent Clostridium Difficile Infection With RBX7455</brief_title>
  <official_title>Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rebiotix Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the&#xD;
      treatment of recurrent CDI in subjects who have had at least one recurrence after a primary&#xD;
      episode (i.e., at least two episodes) and have completed at least two rounds of&#xD;
      standard-of-care oral antibiotic therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">July 22, 2020</completion_date>
  <primary_completion_date type="Actual">July 22, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to recurrence of Clostridium Difficile Infection (CDI)</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients experiencing adverse events</measure>
    <time_frame>approximately 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>RBX7455 Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 days of 4 capsules twice daily RBX7455 for 10 subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RBX7455 Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 days of 4 capsules twice daily RBX7455 for 10 subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RBX7455 Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 days of 2 capsules twice daily RBX7455 for 10 subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RBX7455 Group D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 days of 1 capsule twice daily RBX7455 for 10 subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RBX7455</intervention_name>
    <description>Microbiota capsule(s) given twice daily in the morning, and in the evening.</description>
    <arm_group_label>RBX7455 Group A</arm_group_label>
    <arm_group_label>RBX7455 Group B</arm_group_label>
    <arm_group_label>RBX7455 Group C</arm_group_label>
    <arm_group_label>RBX7455 Group D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. ≥ 18 years old.&#xD;
&#xD;
          2. Medical record documentation of recurrent CDI, defined as at least one recurrence&#xD;
             after a primary episode and has completed at least two rounds of standard-of-care oral&#xD;
             antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be&#xD;
             having less than 3 watery bowel movements at the time of study enrollment for 48 hours&#xD;
             or more.&#xD;
&#xD;
          3. A positive stool test for the presence of C. difficile within 30 days prior to&#xD;
             enrollment and standard C. difficile treatment.&#xD;
&#xD;
          4. Willing and able to swallow capsules.&#xD;
&#xD;
          5. Agrees to abstain from non-dietary probiotics for the duration of the study.&#xD;
&#xD;
          6. Agrees to abstain from vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide&#xD;
             and IVIG for the duration of the study unless prescribed to treat recurrent CDI.&#xD;
&#xD;
          7. Agrees to stop proton pump inhibitors or H2 blocker medications.&#xD;
&#xD;
          8. Agrees to practice a form of effective contraception during study participation.&#xD;
&#xD;
          9. Has a negative urine pregnancy test at the time of enrollment (females of&#xD;
             child-bearing potential only).&#xD;
&#xD;
         10. Willing and able to provide informed consent and HIPAA authorization.&#xD;
&#xD;
         11. Willing and able to complete the required Subject Diary.&#xD;
&#xD;
         12. Willing and able to meet all study requirements, including attending all assessment&#xD;
             visits and phone calls.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. A known history of continued CDI diarrhea, despite being on a course of antibiotics&#xD;
             prescribed for CDI treatment.&#xD;
&#xD;
          2. Requires continuous antibiotic therapy for a condition other than CDI.&#xD;
&#xD;
          3. Previous fecal transplant.&#xD;
&#xD;
          4. Previous treatment with RBX2660.&#xD;
&#xD;
          5. Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's&#xD;
             disease, or microscopic colitis.&#xD;
&#xD;
          6. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.&#xD;
&#xD;
          7. History of chronic diarrhea.&#xD;
&#xD;
          8. History of celiac disease.&#xD;
&#xD;
          9. Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.&#xD;
&#xD;
         10. Unable to stop proton pump inhibitors or H2 blocker medications.&#xD;
&#xD;
         11. Colostomy.&#xD;
&#xD;
         12. Intra-abdominal surgery within the last 60 days.&#xD;
&#xD;
         13. Evidence of active, severe colitis.&#xD;
&#xD;
         14. History of short gut syndrome.&#xD;
&#xD;
         15. Requires the regular use of medications to manage bowel hypermotility.&#xD;
&#xD;
         16. Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).&#xD;
&#xD;
         17. Planned surgery requiring perioperative antibiotics within 3 months of study&#xD;
             enrollment.&#xD;
&#xD;
         18. Life expectancy of &lt; 6 months.&#xD;
&#xD;
         19. Compromised immune system (e.g., HIV infection; AIDS-defining diagnosis or CD4&#xD;
             &lt;200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due&#xD;
             to a medical condition or medication; current or recent (&lt; 90 days) treatment with&#xD;
             chemotherapy; or current or recent (&lt; 90 days) treatment with immunosuppressant&#xD;
             medications.&#xD;
&#xD;
         20. Taking systemic steroids (≥ 20 mg a day or prednisone-equivalent) or is expected to be&#xD;
             on steroids after enrollment through 8 weeks after completing the assigned study&#xD;
             treatment.&#xD;
&#xD;
         21. An absolute neutrophil count of &lt;1000 cells/µL.&#xD;
&#xD;
         22. Known or suspected current (&lt; 90 days) illicit drug use. Note: marijuana use is&#xD;
             allowed.&#xD;
&#xD;
         23. Pregnant, breastfeeding, or intends to become pregnant during study participation.&#xD;
&#xD;
         24. Participating in a clinical trial of another investigational product (drug, device or&#xD;
             other) and has not completed the required follow-up period.&#xD;
&#xD;
         25. Subject, in the opinion of the investigator, for whatever reason, should be excluded&#xD;
             from the study.&#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>Sahil Khanna</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 7, 2020</last_update_submitted>
  <last_update_submitted_qc>December 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Sahil Khanna</investigator_full_name>
    <investigator_title>M.B.B.S.</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02981316
org study id: 15-008828
nct id: NCT02981316
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the
      treatment of recurrent CDI in subjects who have had at least one recurrence after a primary
      episode (i.e., at least two episodes) and have completed at least two rounds of
      standard-of-care oral antibiotic therapy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to recurrence of Clostridium Difficile Infection (CDI)
time frame: approximately 8 weeks
measure: Number of patients experiencing adverse events
time frame: approximately 6 months
arm group label: RBX7455 Group A
arm group type: Active Comparator
description: 4 days of 4 capsules twice daily RBX7455 for 10 subjects.
arm group label: RBX7455 Group B
arm group type: Active Comparator
description: 2 days of 4 capsules twice daily RBX7455 for 10 subjects.
arm group label: RBX7455 Group C
arm group type: Active Comparator
description: 2 days of 2 capsules twice daily RBX7455 for 10 subjects.
arm group label: RBX7455 Group D
arm group type: Active Comparator
description: 2 days of 1 capsule twice daily RBX7455 for 10 subjects.
intervention type: Biological
intervention name: RBX7455
description: Microbiota capsule(s) given twice daily in the morning, and in the evening.
arm group label: RBX7455 Group A
arm group label: RBX7455 Group B
arm group label: RBX7455 Group C
arm group label: RBX7455 Group D
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sahil Khanna
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Sahil Khanna
investigator title: M.B.B.S.
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
sharing ipd: No