<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/NCT02199561</url>
  </required_header>
  <id_info>
    <org_study_id>47055</org_study_id>
    <nct_id>NCT02199561</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease</brief_title>
  <official_title>A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease</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;
      CD 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 CD 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>
      Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6.&#xD;
      Assessments include HBI score, SES-CD score, and serum CRP levels.&#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>HBI score reduction</measure>
    <time_frame>12 and 32 weeks</time_frame>
    <description>Patients with at least 3 point reduction in HBI scores 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>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Fecal Microbiota Transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label single arm delivering fecal transplant to each participant</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fecal Microbiota Transplant</intervention_name>
    <description>Fecal transplant processed from routinely screened universal donor</description>
    <arm_group_label>Fecal Microbiota Transplant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 and &lt; 65 years at the time of screening&#xD;
&#xD;
          2. Diagnosis of ileo-colonic or colonic CD for &gt; 3 months but &lt; 5 years prior to&#xD;
             screening as determined by the investigators&#xD;
&#xD;
          3. Those with mild to moderate CD&#xD;
&#xD;
          4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6&#xD;
             mercaptopurine (6-MP) or methotrexate 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, 6-MP, and methotrexate must be at a stable dose for &gt; 8 weeks&#xD;
&#xD;
          6. ability to provide informed consent&#xD;
&#xD;
          7. evidence of active colonic inflammation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with prior ileo-cecal resection&#xD;
&#xD;
          2. Those who are pregnancy or plan to be pregnant during the trial&#xD;
&#xD;
          3. Those who are breastfeeding or plan to breast feed during the trial&#xD;
&#xD;
          4. Those who are on or have previously failed a biological agent&#xD;
&#xD;
          5. Those who have active perianal disease as determined by investigators&#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;
      </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>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 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>Crohn Disease</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/NCT02199561
org study id: 47055
nct id: NCT02199561
lead sponsor: 
has dmc: Yes
Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for
      CD 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 CD we will carry out a feasibility
      study to determine if serial FMTs can sustain a clinical response and maintain stability of
      transplanted microbiota.
Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6.
      Assessments include HBI score, SES-CD score, and serum CRP levels.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HBI score reduction
time frame: 12 and 32 weeks
description: Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.
arm group label: Fecal Microbiota Transplant
arm group type: Experimental
description: Open label single arm delivering fecal transplant to each participant
intervention type: Biological
intervention name: Fecal Microbiota Transplant
description: Fecal transplant processed from routinely screened universal donor
arm group label: Fecal Microbiota Transplant
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: Crohn Disease