<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/NCT02998112</url>
  </required_header>
  <id_info>
    <org_study_id>FMT-UC-121101</org_study_id>
    <nct_id>NCT02998112</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Hospital of Guangzhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhongshan Hospital Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Second Hospital of Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of&#xD;
      Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial&#xD;
      to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the&#xD;
      efficacy and safety of FMT for patients with moderate or severe UC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Patients with moderate to severe UC will be screened (Mayo&gt;6）.&#xD;
&#xD;
        2. Participants will be divided into control and study groups by double blind.&#xD;
&#xD;
        3. Control group and study group will receive a colonic endoscopy evaluation. And a TET&#xD;
           tube will be fixed at ileocecum.&#xD;
&#xD;
        4. Enema with 5-ASA 4g/day for 7days by TET will be performed as basic therapy for both&#xD;
           control and study group. Study and control group will be given with fecal microbiota&#xD;
           suspension and equal volume of saline by TET for three times every other day in one&#xD;
           week.&#xD;
&#xD;
        5. The follow-up will be performed at 1 week, 4 weeks and 12 weeks after first treatment.&#xD;
           All the participants will receive a endoscopy evaluation at 12 weeks. Clinical&#xD;
           remission, clinical improvement and safety are the primary endpoint at 12 weeks;&#xD;
           Intestinal microbiota changing is recognized as the secondary endpoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical remission</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total Mayo score less than 2 and no signal item more than 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total Mayo score decreased more than 3 or decreased more than 30%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intestinal microbiota changing</measure>
    <time_frame>12 weeks</time_frame>
    <description>The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">188</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5-ASA 4g/day enema through TET for 1 week; 200ml fecal microbiota suspension infusion through TET for 3 times every other day in one week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fecal microbiota transplantation</intervention_name>
    <description>Fecal microbiota which was purified from fresh stool defecated by a healthy donor</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active, moderate to severe severity (Mayo score more than 6)&#xD;
&#xD;
          -  Safety using history of 5-ASA.&#xD;
&#xD;
          -  Able to undergo endoscopy examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunosuppressive drugs and glucocorticoids using in 4 weeks&#xD;
&#xD;
          -  Antibiotic using in 7 days&#xD;
&#xD;
          -  High risk of toxic megacolon&#xD;
&#xD;
          -  Colon cancer or neoplasia in pathophysiology&#xD;
&#xD;
          -  Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney&#xD;
             diseases)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Faming Zhang, MD, PhD</last_name>
      <phone>086-25-58509883</phone>
      <email>fzhang@njmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.</citation>
    <PMID>26363929</PMID>
  </results_reference>
  <results_reference>
    <citation>Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.</citation>
    <PMID>25168749</PMID>
  </results_reference>
  <results_reference>
    <citation>Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.</citation>
    <PMID>25857665</PMID>
  </results_reference>
  <results_reference>
    <citation>Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.</citation>
    <PMID>25836986</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Hospital of Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Faming Zhang</investigator_full_name>
    <investigator_title>Associate professor, Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>fecal microbiota transplantation</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/NCT02998112
org study id: FMT-UC-121101
nct id: NCT02998112
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of
      Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial
      to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the
      efficacy and safety of FMT for patients with moderate or severe UC.
1. Patients with moderate to severe UC will be screened (Mayo>6）.

        2. Participants will be divided into control and study groups by double blind.

        3. Control group and study group will receive a colonic endoscopy evaluation. And a TET
           tube will be fixed at ileocecum.

        4. Enema with 5-ASA 4g/day for 7days by TET will be performed as basic therapy for both
           control and study group. Study and control group will be given with fecal microbiota
           suspension and equal volume of saline by TET for three times every other day in one
           week.

        5. The follow-up will be performed at 1 week, 4 weeks and 12 weeks after first treatment.
           All the participants will receive a endoscopy evaluation at 12 weeks. Clinical
           remission, clinical improvement and safety are the primary endpoint at 12 weeks;
           Intestinal microbiota changing is recognized as the secondary endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Clinical remission
time frame: 12 weeks
description: Total Mayo score less than 2 and no signal item more than 1
measure: Clinical improvement
time frame: 12 weeks
description: Total Mayo score decreased more than 3 or decreased more than 30%
measure: Intestinal microbiota changing
time frame: 12 weeks
description: The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
arm group label: control
arm group type: Placebo Comparator
description: 5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week
arm group label: Study group
arm group type: Experimental
description: 5-ASA 4g/day enema through TET for 1 week; 200ml fecal microbiota suspension infusion through TET for 3 times every other day in one week
intervention type: Drug
intervention name: fecal microbiota transplantation
description: Fecal microbiota which was purified from fresh stool defecated by a healthy donor
arm group label: Study group
intervention type: Drug
intervention name: Saline
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
citation: Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
PMID: 26363929
citation: Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
PMID: 25168749
citation: Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
PMID: 25857665
citation: Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
PMID: 25836986
responsible party type: Principal Investigator
investigator affiliation: The Second Hospital of Nanjing Medical University
investigator full name: Faming Zhang
investigator title: Associate professor, Gastroenterology
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer