<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/NCT02227342</url>
  </required_header>
  <id_info>
    <org_study_id>47056</org_study_id>
    <nct_id>NCT02227342</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis</brief_title>
  <official_title>A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for&#xD;
      IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent&#xD;
      immune response to FMT thereby maintaining sustained clinical improvement and remission.&#xD;
      Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility&#xD;
      study to determine if serial FMTs can sustain a clinical response and maintain stability of&#xD;
      transplanted microbiota.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      same as above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mayo score reduction</measure>
    <time_frame>12 and 32 weeks</time_frame>
    <description>Patients with at least 3 point reduction in partial Mayo scoring index at week 12 and at week 32 in the extension phase.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Fecal Microbiota Transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>serial Fecal Microbiota Transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fecal Microbiota Transplant</intervention_name>
    <description>serial FMT</description>
    <arm_group_label>Fecal Microbiota Transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 and &lt; 65 years&#xD;
&#xD;
          2. Diagnosis of UC for &gt; 3 months but &lt; 5 years prior to screening as determined by the&#xD;
             investigators&#xD;
&#xD;
          3. Those with mild to moderate UC&#xD;
&#xD;
          4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or&#xD;
             6 mercaptopurine (6-MP) for &gt; 3 months&#xD;
&#xD;
          5. Where applicable, those who are taking the following medications must be at a stable&#xD;
             dose defined as:&#xD;
&#xD;
             i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at&#xD;
             a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2&#xD;
             weeks iv) Azathioprine or 6-MP must be at a stable dose for &gt; 8 weeks&#xD;
&#xD;
          6. ability to provide informed consent&#xD;
&#xD;
          7. evidence of active inflammation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those whose disease is limited to the rectum (ie. proctitis)&#xD;
&#xD;
          2. Those with colectomy or diverting ileostomy&#xD;
&#xD;
          3. Those who are pregnancy or plan to be pregnant during the trial&#xD;
&#xD;
          4. Those who are breastfeeding or plan to breast feed during the trial&#xD;
&#xD;
          5. Those who are on or have previously failed a biological agent&#xD;
&#xD;
          6. Those with an active infection requiring antibiotic therapy&#xD;
&#xD;
          7. Those with positive stool cultures for known pathogens such as E coli, Salmonella,&#xD;
             Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of&#xD;
             enrollment&#xD;
&#xD;
          8. Those with positive CMV on colonic tissue biopsy within 2 weeks of screening&#xD;
&#xD;
          9. Those with allergy to ciprofloxacin and metronidazole&#xD;
&#xD;
         10. Those with colonic mucosal dysplasia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- 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/NCT02227342
org study id: 47056
nct id: NCT02227342
lead sponsor: 
has dmc: Yes
Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for
      IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent
      immune response to FMT thereby maintaining sustained clinical improvement and remission.
      Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility
      study to determine if serial FMTs can sustain a clinical response and maintain stability of
      transplanted microbiota.
same as above
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mayo score reduction
time frame: 12 and 32 weeks
description: Patients with at least 3 point reduction in partial Mayo scoring index at week 12 and at week 32 in the extension phase.
arm group label: Fecal Microbiota Transplantation
arm group type: Experimental
description: serial Fecal Microbiota Transplantation
intervention type: Biological
intervention name: Fecal Microbiota Transplant
description: serial FMT
arm group label: Fecal Microbiota Transplantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dina Kao, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Dina Kao
investigator title: Associate Professor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer