<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/NCT03804931</url>
  </required_header>
  <id_info>
    <org_study_id>K-2017-103-01</org_study_id>
    <nct_id>NCT03804931</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation for Ulcerative Colitis</brief_title>
  <official_title>Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou First People's Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension&#xD;
      containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal&#xD;
      microbiome. Fecal microbiota transplantation has been used for several disease，but the&#xD;
      efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further&#xD;
      explored.The investigators propose to determine the efficiency and safety of FMT in patients&#xD;
      with ulcerative colitis(UC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present clinical trial aims to re-establish a gut functionality state of intestinal flora&#xD;
      through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota&#xD;
      isolation from donated fresh stool in lab. Then the microbiota is transplanted to the&#xD;
      intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to&#xD;
      receive FMT at least two times according to associated guidelines and follow-up for at least&#xD;
      three months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">January 20, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
  <phase>Phase 2/Phase 3</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 in patient as assessed using Mayo score</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 in patient as assessed using Mayo score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total Mayo score decreased more than 3</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>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Ulcerative Colitis</condition>
  <condition>Fecal Microbiota Transplantation</condition>
  <arm_group>
    <arm_group_label>Fecal microbiota transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal microbiota transplantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo fecal microbiota transplantation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Infusion of Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional treatments</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fecal microbiota transplantation</intervention_name>
    <description>200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine</description>
    <arm_group_label>Fecal microbiota transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Infusion of Saline</intervention_name>
    <description>Infusion of Saline</description>
    <arm_group_label>placebo fecal microbiota transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-Aminosalicylic acid(5-ASA) and/or Prednisone</intervention_name>
    <description>Mesalazine and/or Prednisone</description>
    <arm_group_label>Fecal microbiota transplantation</arm_group_label>
    <arm_group_label>Traditional treatments</arm_group_label>
    <arm_group_label>placebo fecal microbiota transplantation</arm_group_label>
    <other_name>Mesalazine</other_name>
    <other_name>Prednisone</other_name>
  </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;
          -  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>
  <overall_official>
    <last_name>Yuqiang Nie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou First People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hongli Huang, MM</last_name>
    <phone>86-13631316718</phone>
    <email>honglisums@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Huiting Chen, MM</last_name>
    <phone>86-13926055294</phone>
    <email>gracy1977@tom.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangzhou First People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongli Huang, MM</last_name>
      <phone>86-13631316718</phone>
      <email>honglisums@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Huiting chen, MM</last_name>
      <phone>86-13926055294</phone>
      <email>gracy1977@tom.com</email>
    </contact_backup>
    <investigator>
      <last_name>Haoming Xu, MM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <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>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminosalicylic Acid</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Mesalamine</mesh_term>
  </intervention_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/NCT03804931
org study id: K-2017-103-01
nct id: NCT03804931
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension
      containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal
      microbiome. Fecal microbiota transplantation has been used for several disease，but the
      efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further
      explored.The investigators propose to determine the efficiency and safety of FMT in patients
      with ulcerative colitis(UC).
The present clinical trial aims to re-establish a gut functionality state of intestinal flora
      through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota
      isolation from donated fresh stool in lab. Then the microbiota is transplanted to the
      intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to
      receive FMT at least two times according to associated guidelines and follow-up for at least
      three months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Clinical remission in patient as assessed using Mayo score
time frame: 12 weeks
description: Total Mayo score less than 2 and no signal item more than 1
measure: Clinical improvement in patient as assessed using Mayo score
time frame: 12 weeks
description: Total Mayo score decreased more than 3
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: Fecal microbiota transplantation
arm group type: Experimental
description: Fecal microbiota transplantation
arm group label: placebo fecal microbiota transplantation
arm group type: Sham Comparator
description: Infusion of Saline
arm group label: Traditional treatments
arm group type: Other
description: Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone
intervention type: Procedure
intervention name: Fecal microbiota transplantation
description: 200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
arm group label: Fecal microbiota transplantation
intervention type: Procedure
intervention name: Infusion of Saline
description: Infusion of Saline
arm group label: placebo fecal microbiota transplantation
intervention type: Drug
intervention name: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
description: Mesalazine and/or Prednisone
arm group label: Fecal microbiota transplantation
arm group label: Traditional treatments
arm group label: placebo fecal microbiota transplantation
other name: Mesalazine
other name: Prednisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yuqiang Nie, MD
role: Principal Investigator
affiliation: Guangzhou First People's Hospital
last name: Hongli Huang, MM
phone: 86-13631316718
email: honglisums@126.com
last name: Huiting Chen, MM
phone: 86-13926055294
email: gracy1977@tom.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
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
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Aminosalicylic Acid
mesh term: Prednisone
mesh term: Mesalamine
sharing ipd: No