<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/NCT03298048</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-SPH-17-0614</org_study_id>
    <nct_id>NCT03298048</nct_id>
  </id_info>
  <brief_title>Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)</brief_title>
  <official_title>Phase II. Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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>
      To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in&#xD;
      the treatment of recurrent C. difficile infection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy&#xD;
      study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be&#xD;
      enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal&#xD;
      bacteria with various doses in capsules. All subjects will be followed for approximately 180&#xD;
      days following FMT for safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigators are no longer considering FMT product development for C. difficile.&#xD;
  </why_stopped>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety as Assessed by Number of Participants With Nausea</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as Assessed by Number of Participants With Vomiting</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as Assessed by Number of Participants With Diarrhea</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as Assessed by Number of Participants With Bloating</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as Assessed by Number of Participants With Constipation</measure>
    <time_frame>180 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Recurrent C. Difficile Infection</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Recurrent C. Difficile Infection</condition>
  <arm_group>
    <arm_group_label>Low fecal microbiota dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mid fecal microbiota dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High fecal microbiota dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low fecal microbiota dose</intervention_name>
    <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
    <arm_group_label>Low fecal microbiota dose</arm_group_label>
    <other_name>Fecal microbiota transplantation (FMT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Mid fecal microbiota dose</intervention_name>
    <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
    <arm_group_label>Mid fecal microbiota dose</arm_group_label>
    <other_name>Fecal microbiota transplantation (FMT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High fecal microbiota dose</intervention_name>
    <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
    <arm_group_label>High fecal microbiota dose</arm_group_label>
    <other_name>Fecal microbiota transplantation (FMT)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sexually active female subjects of child-bearing potential must agree to use an&#xD;
             effective method of birth control during the treatment and follow-up period&#xD;
&#xD;
          -  Female subjects of child-bearing potential must have a negative pregnancy test on the&#xD;
             day of the procedure.&#xD;
&#xD;
          -  Subject willing to sign an informed consent form&#xD;
&#xD;
          -  Subject deemed likely to survive for ≥ 1 year after enrollment&#xD;
&#xD;
          -  Able to follow study procedure and follow-ups&#xD;
&#xD;
          -  Subjects' attending physician will provide non-transplant care for the subject&#xD;
&#xD;
          -  Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of&#xD;
             recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin&#xD;
&#xD;
          -  Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of&#xD;
             vancomycin or metronidazole or fidaxomicin) since last bout of CDI&#xD;
&#xD;
          -  Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for&#xD;
             overnight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to take capsules orally&#xD;
&#xD;
          -  Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT&#xD;
&#xD;
          -  Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other&#xD;
             than that found in fortified foods&#xD;
&#xD;
          -  Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV&#xD;
             metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT&#xD;
&#xD;
          -  Severe underlying disease such that the patient is not expected to survive for one or&#xD;
             more years or unstable medical condition requiring daily change in treatments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herbert L DuPont, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTHealth School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>February 20, 2020</results_first_submitted>
  <results_first_submitted_qc>February 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2020</results_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Herbert DuPont</investigator_full_name>
    <investigator_title>Professor of Medicine</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>
    <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 and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03298048/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>2 of the 17 enrolled did not start treatment: one did not start treatment due to physician's concerns about patient taking bowel prep, and the second did not start treatment because of hospitalization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Low Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
        </group>
        <group group_id="P2">
          <title>Mid Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
        </group>
        <group group_id="P3">
          <title>High Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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>Low Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
        </group>
        <group group_id="B2">
          <title>Mid Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
        </group>
        <group group_id="B3">
          <title>High Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</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="4"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" lower_limit="26" upper_limit="90"/>
                    <measurement group_id="B2" value="52" lower_limit="26" upper_limit="75"/>
                    <measurement group_id="B3" value="72.5" lower_limit="34" upper_limit="81"/>
                    <measurement group_id="B4" value="68" lower_limit="26" upper_limit="90"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="15"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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>Number of Patients with Inflammatory bowel disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety as Assessed by Number of Participants With Nausea</title>
        <time_frame>180 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Mid Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
          </group>
          <group group_id="O3">
            <title>High Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Assessed by Number of Participants With Nausea</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety as Assessed by Number of Participants With Vomiting</title>
        <time_frame>180 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Mid Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
          </group>
          <group group_id="O3">
            <title>High Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Assessed by Number of Participants With Vomiting</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety as Assessed by Number of Participants With Diarrhea</title>
        <time_frame>180 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Mid Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
          </group>
          <group group_id="O3">
            <title>High Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Assessed by Number of Participants With Diarrhea</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety as Assessed by Number of Participants With Bloating</title>
        <time_frame>180 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Mid Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
          </group>
          <group group_id="O3">
            <title>High Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Assessed by Number of Participants With Bloating</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety as Assessed by Number of Participants With Constipation</title>
        <time_frame>180 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Mid Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
          </group>
          <group group_id="O3">
            <title>High Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Assessed by Number of Participants With Constipation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Recurrent C. Difficile Infection</title>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Mid Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
          </group>
          <group group_id="O3">
            <title>High Fecal Microbiota Dose</title>
            <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Recurrent C. Difficile Infection</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Low Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days&#xD;
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days</description>
        </group>
        <group group_id="E2">
          <title>Mid Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment&#xD;
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment</description>
        </group>
        <group group_id="E3">
          <title>High Fecal Microbiota Dose</title>
          <description>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days&#xD;
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>60 days after Fecal microbiota transplantation (FMT), stool C. difficile toxin was negative but diarrhea continued. 3 months later, subject had colon removed because of ulcerative colitis and was released from the hospital 3 days after colon removal.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>bloating</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT 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>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Herbert DuPont</name_or_title>
      <organization>UTexas_Houston</organization>
      <phone>713-500-9366</phone>
      <email>herbert.l.dupont@uth.tmc.edu</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/NCT03298048
org study id: HSC-SPH-17-0614
nct id: NCT03298048
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in
      the treatment of recurrent C. difficile infection
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy
      study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be
      enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal
      bacteria with various doses in capsules. All subjects will be followed for approximately 180
      days following FMT for safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Safety as Assessed by Number of Participants With Nausea
time frame: 180 days
measure: Safety as Assessed by Number of Participants With Vomiting
time frame: 180 days
measure: Safety as Assessed by Number of Participants With Diarrhea
time frame: 180 days
measure: Safety as Assessed by Number of Participants With Bloating
time frame: 180 days
measure: Safety as Assessed by Number of Participants With Constipation
time frame: 180 days
measure: Number of Participants With Recurrent C. Difficile Infection
time frame: 6 months
arm group label: Low fecal microbiota dose
arm group type: Active Comparator
description: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
arm group label: Mid fecal microbiota dose
arm group type: Active Comparator
description: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
arm group label: High fecal microbiota dose
arm group type: Active Comparator
description: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
intervention type: Biological
intervention name: Low fecal microbiota dose
description: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
arm group label: Low fecal microbiota dose
other name: Fecal microbiota transplantation (FMT)
intervention type: Biological
intervention name: Mid fecal microbiota dose
description: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
arm group label: Mid fecal microbiota dose
other name: Fecal microbiota transplantation (FMT)
intervention type: Biological
intervention name: High fecal microbiota dose
description: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
arm group label: High fecal microbiota dose
other name: Fecal microbiota transplantation (FMT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Herbert L DuPont, MD
role: Principal Investigator
affiliation: UTHealth School of Public Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Herbert DuPont
investigator title: Professor of Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
mesh term: Recurrence
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed
point of contact: 