<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/NCT04436874</url>
  </required_header>
  <id_info>
    <org_study_id>FMT-IBD-190923</org_study_id>
    <nct_id>NCT04436874</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease</brief_title>
  <acronym>FMT-IBD</acronym>
  <official_title>Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: the Role of Selection of the Dai Ethnic Group as Donor Source in Terms of Treatment Efficacy and Pathogenic Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Kunming Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to&#xD;
      affected subjects, is a method to restore a balanced gut microbiota and has attracted great&#xD;
      interest in recent years due to its efficacy and ease of use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FMT is now recommended as the most effective therapy for CDI not responding to standard&#xD;
      therapies1.Recent studies have suggested that dysbiosis is associated with a variety of&#xD;
      disorders, and that FMT could be a useful treatment. Randomized controlled trial has been&#xD;
      conducted in a number of disorders including ulcerative colitis (UC). Our study is aims to&#xD;
      Fecal microbiota transplantation in the treatment of Inflammatory Bowel Disease, the role of&#xD;
      selection of the Dai ethnic group as donor source in terms of treatment efficacy and&#xD;
      pathogenic mechanisms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 23, 2019</start_date>
  <completion_date type="Anticipated">December 23, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 23, 2021</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>steroid-free clinical remission and endoscopic remission</measure>
    <time_frame>3 years</time_frame>
    <description>The primary outcome is a composite of steroid-free clinical remission together with endoscopic remission or response at week 6, defined as defined as a total Mayo score of ≤2 points with no individual sub-score &gt;1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Steroid-free clinical remission</measure>
    <time_frame>3 years</time_frame>
    <description>defined as combined Mayo sub-scores of 1 or less for rectal bleeding plus stool frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steroid-free clinical response</measure>
    <time_frame>3 years</time_frame>
    <description>defined as either a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo sub-scores, or both</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steroid-free endoscopic response</measure>
    <time_frame>3 years</time_frame>
    <description>defined as a Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microbiological change</measure>
    <time_frame>3 years</time_frame>
    <description>Changes in microbial composition (including bacteriome, virome and fungome), function and metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbiome of stool</measure>
    <time_frame>3 years</time_frame>
    <description>Change in microbiome of stool (including bacteriome, virome and fungome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in microbiome compared between subjects in different treatment arm</measure>
    <time_frame>3 years</time_frame>
    <description>Difference in microbiome (including bacteriome, virome and fungome) compared between subjects in different treatment arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of microbiome</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of microbiome (including bacteriome, virome and fungome) derived from recipient, donor or both in subjects who received FMT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in microbiome compared between subjects who have weight loss and those do not have weight loss</measure>
    <time_frame>3 years</time_frame>
    <description>Difference in microbiome (including bacteriome, virome and fungome) compared between subjects who have weight loss and those do not have weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbial factors that are associated with percentage of body weight loss</measure>
    <time_frame>3 years</time_frame>
    <description>Microbial factors (including bacteriome, virome and fungome) that are associated with percentage of body weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome</measure>
    <time_frame>3 years</time_frame>
    <description>Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Fecal Microbiota Transplantation</condition>
  <arm_group>
    <arm_group_label>Han ethnic-UC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ulcerative colitis subjects will be treated with bacterial solution from Han ethnic by endoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Han ethnic-CD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Crohn's disease subjects will be treated with bacterial solution from Han ethnic by endoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dai ethnic-UC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ulcerative colitis subjects will be treated with bacterial solution from Dai ethnic by endoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dai ethnic-CD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Crohn's disease subjects will be treated with bacterial solution from Dai ethnic by endoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>endoscopy</intervention_name>
    <description>transplant infusion of feces from healthy donors into affected subjects</description>
    <arm_group_label>Dai ethnic-CD</arm_group_label>
    <arm_group_label>Dai ethnic-UC</arm_group_label>
    <arm_group_label>Han ethnic-CD</arm_group_label>
    <arm_group_label>Han ethnic-UC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75 years inclusive (no limit on gender)&#xD;
&#xD;
          -  Confirmed diagnosis of ulcerative colitis for &gt; 3 months, according to established&#xD;
             clinical,endoscopic and histologic criteria&#xD;
&#xD;
          -  Currently active mild-moderate ulcerative colitis, as measured by a Mayo score of&#xD;
             4-10, in which endoscopy sub-score ≥ 1 and physician's global assessment sub-score ≤ 2&#xD;
&#xD;
          -  Written informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are unable to give consent or who have conditions rendering them&#xD;
             incapable to answer questionnaires or provide samples.&#xD;
&#xD;
          -  Females who are pregnant or actively trying to fall pregnant&#xD;
&#xD;
          -  Subjects unwilling to practice an effective method of contraception throughout the&#xD;
             study period&#xD;
&#xD;
          -  Subjects defined as in remission by the investigator&#xD;
&#xD;
          -  Evidence or history of toxic megacolon&#xD;
&#xD;
          -  Isolated proctitis &lt; 5 cm&#xD;
&#xD;
          -  A diagnosis of Crohn's Disease or indeterminate colitis&#xD;
&#xD;
          -  Subjects with perianal disease (e.g. fistulae, pre-existing fissures)&#xD;
&#xD;
          -  Significant gastrointestinal surgery e.g. colon resection, colectomy :Minor&#xD;
             gastrointestinal surgery will be reviewed on a case by case basis by the&#xD;
             investigator;Regarding appendicectomy, only exclude patients who had appendicectomy &lt;&#xD;
             3 months ago)&#xD;
&#xD;
          -  Subjects taking antimicrobials (antibiotics, antifungals, antivirals) for any reason,&#xD;
             including antibiotics for ulcerative colitis, in the preceding 4 weeks&#xD;
&#xD;
          -  Subjects who are steroid dependent and requiring &gt; 20mg prednisone or &gt; 9mg budesonide&#xD;
             daily at the time of enrolment&#xD;
&#xD;
          -  Subjects who have recently taken or are actively taking or expected to require&#xD;
             prohibited medication/s during the study period including follow-up. These&#xD;
             include:Rectal therapy including corticosteroid, 5-aminosalicylate within 2 weeks&#xD;
             before first FMT;Treatment with biologic agents e.g. infliximab, adalimumab,&#xD;
             vedolizumab, within 12 weeks before first FMT;Treatment with other major&#xD;
             immunosuppressant agents including calcineurin inhibitors, anti-neoplastic agents,&#xD;
             lymphocyte depleting biological agents within 12 weeks before first FMT;Probiotic&#xD;
             therapy within 4 weeks before first FMT;Experimental / trial drug protocol involvement&#xD;
             within 12 weeks before first FMT;Anti-mycobacterial (TB or MAC) therapy within 4 weeks&#xD;
             before first FMT&#xD;
&#xD;
        Allowed concomitant medications:&#xD;
&#xD;
        The following drugs are allowed as long as the dose is stable preceding first FMT for the&#xD;
        noted time:&#xD;
&#xD;
          -  oral 5-aminosalicylates (stable dose for 4 weeks)&#xD;
&#xD;
          -  thiopurines and methotrexate (on medication for ≥ 90 days and dose stable for 4 weeks)&#xD;
&#xD;
          -  oral prednisolone (dose ≤ 20mg daily and stable for 2 weeks) During the study,&#xD;
             subjects should remained on the same dose of oral 5-aminosalicylate, thiopurine, and&#xD;
             methotrexate. For oral prednisolone, dose must be tapered at a rate up to 2.5mg per&#xD;
             week so that subjects would be steroid-free by week 8.&#xD;
&#xD;
        Prohibited medications:&#xD;
&#xD;
        The following drugs for are prohibited for the noted time:&#xD;
&#xD;
          -  Rectal therapies including corticosteroid, 5-aminosalicylate (for 2 weeks before first&#xD;
             FMT and during study period)&#xD;
&#xD;
          -  Antibiotics, antibiotics, antifungals, antivirals, probiotic or prebiotic preparations&#xD;
             (for 4 weeks before first FMT and during study period)&#xD;
&#xD;
          -  Rectal therapies including corticosteroid, 5-aminosalicylate (for 2 weeks before first&#xD;
             FMT and during study period)&#xD;
&#xD;
          -  Biological therapies or calcineurin inhibitors (for 12 weeks before first FMT and&#xD;
             during study period)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Y L Miao, doctor</last_name>
    <role>Study Director</role>
    <affiliation>First Affiliated Hospital of Kunming Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endoscopy</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Kunming Medical University</investigator_affiliation>
    <investigator_full_name>Yinglei Miao</investigator_full_name>
    <investigator_title>Clinical professor，Director of Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>Crohn's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</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/NCT04436874
org study id: FMT-IBD-190923
nct id: NCT04436874
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to
      affected subjects, is a method to restore a balanced gut microbiota and has attracted great
      interest in recent years due to its efficacy and ease of use.
FMT is now recommended as the most effective therapy for CDI not responding to standard
      therapies1.Recent studies have suggested that dysbiosis is associated with a variety of
      disorders, and that FMT could be a useful treatment. Randomized controlled trial has been
      conducted in a number of disorders including ulcerative colitis (UC). Our study is aims to
      Fecal microbiota transplantation in the treatment of Inflammatory Bowel Disease, the role of
      selection of the Dai ethnic group as donor source in terms of treatment efficacy and
      pathogenic mechanisms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: steroid-free clinical remission and endoscopic remission
time frame: 3 years
description: The primary outcome is a composite of steroid-free clinical remission together with endoscopic remission or response at week 6, defined as defined as a total Mayo score of ≤2 points with no individual sub-score >1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score
measure: Steroid-free clinical remission
time frame: 3 years
description: defined as combined Mayo sub-scores of 1 or less for rectal bleeding plus stool frequency
measure: Steroid-free clinical response
time frame: 3 years
description: defined as either a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo sub-scores, or both
measure: Steroid-free endoscopic response
time frame: 3 years
description: defined as a Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline
measure: microbiological change
time frame: 3 years
description: Changes in microbial composition (including bacteriome, virome and fungome), function and metabolite
measure: Change in microbiome of stool
time frame: 3 years
description: Change in microbiome of stool (including bacteriome, virome and fungome)
measure: Difference in microbiome compared between subjects in different treatment arm
time frame: 3 years
description: Difference in microbiome (including bacteriome, virome and fungome) compared between subjects in different treatment arm
measure: Proportion of microbiome
time frame: 3 years
description: Proportion of microbiome (including bacteriome, virome and fungome) derived from recipient, donor or both in subjects who received FMT
measure: Difference in microbiome compared between subjects who have weight loss and those do not have weight loss
time frame: 3 years
description: Difference in microbiome (including bacteriome, virome and fungome) compared between subjects who have weight loss and those do not have weight loss
measure: Microbial factors that are associated with percentage of body weight loss
time frame: 3 years
description: Microbial factors (including bacteriome, virome and fungome) that are associated with percentage of body weight loss
measure: Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
time frame: 3 years
description: Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
arm group label: Han ethnic-UC
arm group type: Experimental
description: Ulcerative colitis subjects will be treated with bacterial solution from Han ethnic by endoscopy
arm group label: Han ethnic-CD
arm group type: Experimental
description: Crohn's disease subjects will be treated with bacterial solution from Han ethnic by endoscopy
arm group label: Dai ethnic-UC
arm group type: Experimental
description: Ulcerative colitis subjects will be treated with bacterial solution from Dai ethnic by endoscopy
arm group label: Dai ethnic-CD
arm group type: Experimental
description: Crohn's disease subjects will be treated with bacterial solution from Dai ethnic by endoscopy
intervention type: Device
intervention name: endoscopy
description: transplant infusion of feces from healthy donors into affected subjects
arm group label: Dai ethnic-CD
arm group label: Dai ethnic-UC
arm group label: Han ethnic-CD
arm group label: Han ethnic-UC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Y L Miao, doctor
role: Study Director
affiliation: First Affiliated Hospital of Kunming Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Kunming Medical University
investigator full name: Yinglei Miao
investigator title: Clinical professor，Director of Gastroenterology
mesh term: Inflammatory Bowel Diseases
sharing ipd: No