<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/NCT02254811</url>
  </required_header>
  <id_info>
    <org_study_id>48233</org_study_id>
    <nct_id>NCT02254811</nct_id>
  </id_info>
  <brief_title>FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff</brief_title>
  <official_title>A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and&#xD;
      lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized&#xD;
      successfully. Endoscopic delivery requires significant health care utilization and associated&#xD;
      cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality,&#xD;
      which would significantly reduce patient discomfort, procedure related risks and health care&#xD;
      costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1&#xD;
      to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1&#xD;
      mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical&#xD;
      cost for previous treatment is collected as well at pt perspective and QoL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2014</start_date>
  <completion_date type="Actual">September 13, 2017</completion_date>
  <primary_completion_date type="Actual">December 12, 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients without recurrent CDI</measure>
    <time_frame>12 weeks after treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Enterocolitis Clostridium Difficile Recurrent</condition>
  <arm_group>
    <arm_group_label>Delivery via capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal microbiota transplant is delivered by oral capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delivery via colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal microbiota transplant delivered by colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fecal Microbiota Transplant</intervention_name>
    <description>transfer of healthy human gut bacteria to restore the microbiome</description>
    <arm_group_label>Delivery via capsule</arm_group_label>
    <arm_group_label>Delivery via colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 and &lt; 90 years at the time of Screening.&#xD;
&#xD;
          2. Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as&#xD;
             presence of diarrhea (&gt; 3 unformed stools/24 hours) associate with positive stool&#xD;
             Clostridium difficle toxin, occurring within 3 months of each other.&#xD;
&#xD;
          3. CDI infection under symptomatic control with &lt; 3 loose/unformed BM's per 24 h period&#xD;
             for at least 2 consecutive days before procedure.&#xD;
&#xD;
          4. Those with ability to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with complicated CDI, defined as white blood cell&gt;35 or &lt;0.5 x 109/L,&#xD;
             significant abdominal pain and distension with evidence of toxic megacolon or&#xD;
             pseudomembranous colitis, hypotension defined as systolic blood pressure &lt; 90 mmHg&#xD;
             unresponsive to fluid resuscitation, end organ failure, or requiring intensive care&#xD;
             unit admission.&#xD;
&#xD;
          2. Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory&#xD;
             bowel disease unless they are in remission for at least 3 months prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina Kao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Dina Kao</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Recurrence</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/NCT02254811
org study id: 48233
nct id: NCT02254811
lead sponsor: 
collaborator: 
has dmc: Yes
Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and
      lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized
      successfully. Endoscopic delivery requires significant health care utilization and associated
      cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality,
      which would significantly reduce patient discomfort, procedure related risks and health care
      costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.
Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1
      to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1
      mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical
      cost for previous treatment is collected as well at pt perspective and QoL.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients without recurrent CDI
time frame: 12 weeks after treatment
arm group label: Delivery via capsule
arm group type: Experimental
description: Fecal microbiota transplant is delivered by oral capsules
arm group label: Delivery via colonoscopy
arm group type: Experimental
description: Fecal microbiota transplant delivered by colonoscopy
intervention type: Biological
intervention name: Fecal Microbiota Transplant
description: transfer of healthy human gut bacteria to restore the microbiome
arm group label: Delivery via capsule
arm group label: Delivery via colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dina Kao, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Dina Kao
investigator title: Associate Professor
mesh term: Enterocolitis
mesh term: Recurrence
sharing ipd: No