<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/NCT04434872</url>
  </required_header>
  <id_info>
    <org_study_id>0680-14-TLV</org_study_id>
    <nct_id>NCT04434872</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <brief_summary>
    <textblock>
      Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal&#xD;
      bacterial population (dysbiosis). A promising therapy for restoration of the altered balance&#xD;
      of the enteric microbiota is fecal microbial transplantation (FMT).&#xD;
&#xD;
      FMT will ameliorate colitis via alterations of patients' microbiota and their&#xD;
      proteolytic-dependent effect on epithelial permeability.&#xD;
&#xD;
      Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota&#xD;
      Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal&#xD;
      enemas. The treating physicians and the patients will be blinded for the treatment arm.&#xD;
&#xD;
      At the FMT visit (first week), blood and stool samples will be taken and patients will be&#xD;
      filling out questionnaires to assess disease activity level.&#xD;
&#xD;
      Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT,&#xD;
      patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as&#xD;
      well.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of budget&#xD;
  </why_stopped>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>8 weeks after FMT</time_frame>
    <description>A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histological remission assessed by sigmoidoscopy</measure>
    <time_frame>8 weeks after FMT</time_frame>
    <description>Will be assessed by sigmoidoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term remission assessed through questionnaires</measure>
    <time_frame>one year after FMT</time_frame>
    <description>Will be assessed through questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>FMT from a healthy donor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo FMT 4 times during the study:&#xD;
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:&#xD;
A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.&#xD;
Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FMT from a self donated stool sample</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will undergo FMT 4 times during the study:&#xD;
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:&#xD;
A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.&#xD;
Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colonoscopy</intervention_name>
    <description>Fecal microbiota transplantation through colonoscopy</description>
    <arm_group_label>FMT from a healthy donor</arm_group_label>
    <arm_group_label>FMT from a self donated stool sample</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastroscopy</intervention_name>
    <description>Fecal microbiota transplantation through gastroscopy</description>
    <arm_group_label>FMT from a healthy donor</arm_group_label>
    <arm_group_label>FMT from a self donated stool sample</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fecal Microbiota</intervention_name>
    <arm_group_label>FMT from a healthy donor</arm_group_label>
    <arm_group_label>FMT from a self donated stool sample</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Enema</intervention_name>
    <description>Fecal microbiota transplantation through enema</description>
    <arm_group_label>FMT from a healthy donor</arm_group_label>
    <arm_group_label>FMT from a self donated stool sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 3 month diagnosis of ulcerative colitis&#xD;
&#xD;
          -  Active Colitis disease with endoscopic score &gt;0&#xD;
&#xD;
          -  Ability to sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute neutrophilia (under 500 neutrophils)&#xD;
&#xD;
          -  Clostridium difficile infection&#xD;
&#xD;
          -  Exposure to antibiotics 2 weeks prior to enrollment.&#xD;
&#xD;
          -  Severe immune deficiency&#xD;
&#xD;
          -  Hospitalization&#xD;
&#xD;
          -  Proctitis involving less than 10cm of the rectum&#xD;
&#xD;
          -  Malignancy with the past 5 years (excluding BCC)&#xD;
&#xD;
          -  An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or&#xD;
             of immunomodulators or biologic therapy within the past 12 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Gastroentherology</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2015</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Microbiota</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <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/NCT04434872
org study id: 0680-14-TLV
nct id: NCT04434872
lead sponsor: 
Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal
      bacterial population (dysbiosis). A promising therapy for restoration of the altered balance
      of the enteric microbiota is fecal microbial transplantation (FMT).

      FMT will ameliorate colitis via alterations of patients' microbiota and their
      proteolytic-dependent effect on epithelial permeability.

      Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota
      Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal
      enemas. The treating physicians and the patients will be blinded for the treatment arm.

      At the FMT visit (first week), blood and stool samples will be taken and patients will be
      filling out questionnaires to assess disease activity level.

      Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT,
      patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as
      well.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Clinical improvement
time frame: 8 weeks after FMT
description: A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE
measure: Histological remission assessed by sigmoidoscopy
time frame: 8 weeks after FMT
description: Will be assessed by sigmoidoscopy
measure: Long term remission assessed through questionnaires
time frame: one year after FMT
description: Will be assessed through questionnaires
arm group label: FMT from a healthy donor
arm group type: Active Comparator
description: Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
arm group label: FMT from a self donated stool sample
arm group type: Placebo Comparator
description: Patients will undergo FMT 4 times during the study:
first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through:
A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.
Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.
intervention type: Procedure
intervention name: Colonoscopy
description: Fecal microbiota transplantation through colonoscopy
arm group label: FMT from a healthy donor
arm group label: FMT from a self donated stool sample
intervention type: Procedure
intervention name: Gastroscopy
description: Fecal microbiota transplantation through gastroscopy
arm group label: FMT from a healthy donor
arm group label: FMT from a self donated stool sample
intervention type: Drug
intervention name: Fecal Microbiota
arm group label: FMT from a healthy donor
arm group label: FMT from a self donated stool sample
intervention type: Procedure
intervention name: Enema
description: Fecal microbiota transplantation through enema
arm group label: FMT from a healthy donor
arm group label: FMT from a self donated stool sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer