<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/NCT03016780</url>
  </required_header>
  <id_info>
    <org_study_id>FMT-IBD</org_study_id>
    <nct_id>NCT03016780</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation for Ulcerative Colitis</brief_title>
  <acronym>FMTFUC</acronym>
  <official_title>Evaluation of The Effect of Fecal Microbiota Transplantation on Ulcerative Colitis and Its Mechanism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Chengdu Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Chengdu Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ulcerative colitis is a common digestive system disease, the incidence is increasing in&#xD;
      recent years.It is reported that the occurrence and development of ulcerative colitis is&#xD;
      closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be&#xD;
      related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild&#xD;
      intestinal flora has been used for several disease，but the efficacy of ulcerative colitis by&#xD;
      fecal microbiota transplantation needs to be further explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who meet the inclusion crit ulcerative colitisby will be separated into two parts&#xD;
      depending on accepation or refuse of Fecal microbiota transplantation.Blood specimen from&#xD;
      patients will be collected to analysis intestinal mucosal immunity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2018</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>According to the inclusion criteria, the patients were randomly divided into experimental group and control group. Before and after the fecal microbiota transplantation, patients were asked about the history of abdominal pain, abdominal distension, diarrhea and so on,at the same time, monitoring heart rate, respiration, pulse, blood pressure is necessary and determinating liver function, renal function, electrolytes, blood coagulation, blood lipids, endotoxins and other biochemical tests to evaluate clinical efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of clinical symptoms of the treatment</measure>
    <time_frame>4 week</time_frame>
    <description>We evaluate the improvement of clinical symptoms of the treatment through Clinical Symptom Score of ulcerative colitis and Endoscopic Rachmilewitz Scoreto.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The influence of interleukin-10 after the treatment</measure>
    <time_frame>0-4 week</time_frame>
    <description>Inflammatory factors such as interleukin-10 in the blood of patients with ulcerative colitis and indicators of disease activity such as erythrocyte sedimentation rate, C-reactive protein are often elevated, we want to study the change above indicators before and after treatment, reflecting the improvement of Inflammation of ulcerative colitis and study the effect of its activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal mucosal immunity</measure>
    <time_frame>4 week</time_frame>
    <description>Ulcerative colitis is an autoimmune disease, it is closely related to the secretory SIgA, and content of serum secretory SIgA of ulcerative colitis patients often decreased. By measuring serum secreted SIgA before and after the treatment of to reflect the immune function of ulcerative colitis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ulcerative Colitis</condition>
  <condition>Intestinal Bacteria Flora Disturbance</condition>
  <condition>Fecal Microbiota Transplantation</condition>
  <arm_group>
    <arm_group_label>Treatment in part 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo in part 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fecal Microbiota Transplantation</intervention_name>
    <description>Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.</description>
    <arm_group_label>Treatment in part 1</arm_group_label>
    <other_name>Fecal Microbiota Transplantation(FMT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Normal saline and the traditional treatments for ulcerative colitisin in part 2.</description>
    <arm_group_label>Placebo in part 2</arm_group_label>
    <other_name>Normal Saline(NS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. subjects voluntarily participate in the trial and sign informed consent;&#xD;
&#xD;
          2. sex is not limited,ranging from 18 to 75 years old;&#xD;
&#xD;
          3. meet the diagnostic criteria for ulcerative colitis in patients;&#xD;
&#xD;
          4. be able to communicate well with the researchers and follow the verification&#xD;
             requirements.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Pregnancy or people who are not to give informed consent;&#xD;
&#xD;
          2. use of major immunosuppressive agents, including the use of large doses of&#xD;
             glucocorticoids, calcineurin inhibitors, mTOR inhibitors, depleted lymphocyte&#xD;
             biological agents, anti-tumor necrosis factor and other conditions; chemotherapy of&#xD;
             antineoplastic drugs;&#xD;
&#xD;
          3. decompensated cirrhosis, progressive AIDS and HIV infectionor other serious&#xD;
             immunodeficiency disease;&#xD;
&#xD;
          4. use of antibiotics and probiotics within six weeks;&#xD;
&#xD;
          5. with severe complications such as local stenosis, intestinal obstruction, intestinal&#xD;
             perforation, toxic colon expansion, colon cancer, rectal cancer patients;&#xD;
&#xD;
          6. combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system&#xD;
             and other serious primary disease, mental illness.&#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>Xiaoan Li, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital of Chengdu Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoan Li, Ph.D</last_name>
    <phone>+8613880868858</phone>
    <email>zqzy1983@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>IEC of Chengdu Medical College</name>
      <address>
        <city>Chendu</city>
        <zip>610500</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoan Li, Ph.D</last_name>
      <phone>+8613680868858</phone>
      <email>zqzy1983@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 7, 2017</last_update_submitted>
  <last_update_submitted_qc>January 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>Intestinal Bacteria Flora Disturbance</keyword>
  <keyword>Fecal Microbiota Transplantation</keyword>
  <keyword>Intestinal Mucosal Immunity</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>
    <mesh_term>Dysbiosis</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/NCT03016780
org study id: FMT-IBD
nct id: NCT03016780
lead sponsor: 
has dmc: Yes
Ulcerative colitis is a common digestive system disease, the incidence is increasing in
      recent years.It is reported that the occurrence and development of ulcerative colitis is
      closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be
      related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild
      intestinal flora has been used for several disease，but the efficacy of ulcerative colitis by
      fecal microbiota transplantation needs to be further explored.
Patients who meet the inclusion crit ulcerative colitisby will be separated into two parts
      depending on accepation or refuse of Fecal microbiota transplantation.Blood specimen from
      patients will be collected to analysis intestinal mucosal immunity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of treatment-emergent adverse events
time frame: 3 months
description: According to the inclusion criteria, the patients were randomly divided into experimental group and control group. Before and after the fecal microbiota transplantation, patients were asked about the history of abdominal pain, abdominal distension, diarrhea and so on,at the same time, monitoring heart rate, respiration, pulse, blood pressure is necessary and determinating liver function, renal function, electrolytes, blood coagulation, blood lipids, endotoxins and other biochemical tests to evaluate clinical efficacy.
measure: Improvement of clinical symptoms of the treatment
time frame: 4 week
description: We evaluate the improvement of clinical symptoms of the treatment through Clinical Symptom Score of ulcerative colitis and Endoscopic Rachmilewitz Scoreto.
measure: The influence of interleukin-10 after the treatment
time frame: 0-4 week
description: Inflammatory factors such as interleukin-10 in the blood of patients with ulcerative colitis and indicators of disease activity such as erythrocyte sedimentation rate, C-reactive protein are often elevated, we want to study the change above indicators before and after treatment, reflecting the improvement of Inflammation of ulcerative colitis and study the effect of its activity.
measure: Intestinal mucosal immunity
time frame: 4 week
description: Ulcerative colitis is an autoimmune disease, it is closely related to the secretory SIgA, and content of serum secretory SIgA of ulcerative colitis patients often decreased. By measuring serum secreted SIgA before and after the treatment of to reflect the immune function of ulcerative colitis.
arm group label: Treatment in part 1
arm group type: Active Comparator
description: Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1.
arm group label: Placebo in part 2
arm group type: Placebo Comparator
description: The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines.
intervention type: Other
intervention name: Fecal Microbiota Transplantation
description: Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.
arm group label: Treatment in part 1
other name: Fecal Microbiota Transplantation(FMT)
intervention type: Other
intervention name: Normal Saline
description: Normal saline and the traditional treatments for ulcerative colitisin in part 2.
arm group label: Placebo in part 2
other name: Normal Saline(NS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaoan Li, Ph.D
role: Study Chair
affiliation: First Affiliated Hospital of Chengdu Medical College
last name: Xiaoan Li, Ph.D
phone: +8613880868858
email: zqzy1983@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Dysbiosis
sharing ipd: No