<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/NCT03014505</url>
  </required_header>
  <id_info>
    <org_study_id>FMT-GYH</org_study_id>
    <nct_id>NCT03014505</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation for Decompensated Cirrhosis</brief_title>
  <acronym>FMTDC</acronym>
  <official_title>Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial</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>
      Imbalance of gut bacteria is suspected to play a key role driving the progression of&#xD;
      cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will&#xD;
      determine if fecal microbiota transplantation is an effective and safe treatment for&#xD;
      decompensated cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two groups of inpatients with decompensated cirrhosis will be randomized using random&#xD;
      sequence generator into experimental and control groups. Two groups will given traditional&#xD;
      treatments and experimental group will added treatment with fecal microbiota transplantation&#xD;
      via endoscope and/or cenema.The liver function parameters, adverse events complication,&#xD;
      systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the&#xD;
      intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month&#xD;
      and 3 months &amp; subjects will be clinically assessed for improvement or worsening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">March 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>Number of adverse events complication rate in all patients in both groups</measure>
    <time_frame>3 months</time_frame>
    <description>Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in liver function test as compared to baseline in both groups.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in systemic inflammatory markers like TNF-α in both groups.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in systemic inflammatory markers like IL-6 in both groups.</measure>
    <time_frame>3 months</time_frame>
    <description>Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in systemic inflammatory markers like serum endotoxins in both groups.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diamine oxidase（DAO）</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological changes in the intestinal biopsy in both groups.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition</measure>
    <time_frame>3 months</time_frame>
    <description>Deep sequencing of the microbiota at baseline and post-FMT.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Decompensated Cirrhosis</condition>
  <condition>Fecal Microbiota Transplantation</condition>
  <arm_group>
    <arm_group_label>FMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The traditional treatments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FMT</intervention_name>
    <description>Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1</description>
    <arm_group_label>FMT</arm_group_label>
    <other_name>Fecal Microbiota Transplantation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional treatments</intervention_name>
    <description>traditional treatments for Decompensated Cirrhosis in part 2</description>
    <arm_group_label>The traditional treatments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;18 years of age&#xD;
&#xD;
          2. Agreed to participate in this clinical study and signed informed consent, follow-up&#xD;
             time greater than 3 months.&#xD;
&#xD;
          3. Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver&#xD;
             function damage, portal hypertension clinical manifestations, laboratory and imaging&#xD;
             studies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing bacterial infection requiring antibiotic treatment.&#xD;
&#xD;
          2. current or history of significant alcohol consumption for a period of more than 3&#xD;
             consecutive months within 1 year prior to screening (significant alcohol consumption&#xD;
             is defined as more than 20 g/day in females and more than 30 g/day in males, on&#xD;
             average).&#xD;
&#xD;
          3. consecutive months within 1 year prior to screening.&#xD;
&#xD;
          4. Treatment with antibiotics or probiotics in the preceding 3 months.&#xD;
&#xD;
          5. Inability to safely perform an GastroIntestinal endoscopy.&#xD;
&#xD;
          6. No history of recent spontaneous bacterial peritonitis or gastrointestinal&#xD;
             bleeding.(14 days).&#xD;
&#xD;
          7. Human Immunodeficiency Virus (HIV) infection.&#xD;
&#xD;
          8. Active, serious medical disease with likely life expectancy less than 5 years.&#xD;
&#xD;
          9. Active substance abuse including inhaled or injection drugs in the year prior to&#xD;
             screening.&#xD;
&#xD;
         10. pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use&#xD;
             effective birth control during the trial, breast feeding.&#xD;
&#xD;
         11. Any other condition which, in the opinion of the investigator, would impede compliance&#xD;
             or hinder completion of the study.&#xD;
&#xD;
         12. History of severe (anaphylactic) food allergy.&#xD;
&#xD;
         13. History of gastroparesis or altered gastric motility -&#xD;
&#xD;
         14. Psychiatric disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiao-an Li, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital of Chengdu Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Zhou, Ph.D</last_name>
    <phone>+86-18981941992</phone>
    <email>zqlvzy319@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>Xiao-an Li, doctor</last_name>
      <phone>+8613680868858</phone>
      <email>zqzy1983@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cirrhosis</keyword>
  <keyword>Fecal Microbiota Transplantation</keyword>
  <keyword>Intestinal flora</keyword>
  <keyword>Intestinal mucosal barrier</keyword>
  <keyword>Intestinal Bacteria Flora Disturbance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT03014505
org study id: FMT-GYH
nct id: NCT03014505
lead sponsor: 
has dmc: Yes
Imbalance of gut bacteria is suspected to play a key role driving the progression of
      cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will
      determine if fecal microbiota transplantation is an effective and safe treatment for
      decompensated cirrhosis.
Two groups of inpatients with decompensated cirrhosis will be randomized using random
      sequence generator into experimental and control groups. Two groups will given traditional
      treatments and experimental group will added treatment with fecal microbiota transplantation
      via endoscope and/or cenema.The liver function parameters, adverse events complication,
      systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the
      intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month
      and 3 months & subjects will be clinically assessed for improvement or worsening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of adverse events complication rate in all patients in both groups
time frame: 3 months
description: Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.
measure: Improvement in liver function test as compared to baseline in both groups.
time frame: 3 months
measure: Reduction in systemic inflammatory markers like TNF-α in both groups.
time frame: 3 months
measure: Reduction in systemic inflammatory markers like IL-6 in both groups.
time frame: 3 months
description: Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.
measure: Reduction in systemic inflammatory markers like serum endotoxins in both groups.
time frame: 3 months
measure: Diamine oxidase（DAO）
time frame: 3 months
measure: Histological changes in the intestinal biopsy in both groups.
time frame: 3 months
measure: Microbiota composition
time frame: 3 months
description: Deep sequencing of the microbiota at baseline and post-FMT.
arm group label: FMT
arm group type: Experimental
description: Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments
arm group label: The traditional treatments
arm group type: Active Comparator
intervention type: Biological
intervention name: FMT
description: Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
arm group label: FMT
other name: Fecal Microbiota Transplantation
intervention type: Other
intervention name: traditional treatments
description: traditional treatments for Decompensated Cirrhosis in part 2
arm group label: The traditional treatments
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Xiao-an Li, Ph.D
role: Study Chair
affiliation: First Affiliated Hospital of Chengdu Medical College
last name: Yan Zhou, Ph.D
phone: +86-18981941992
email: zqlvzy319@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
sharing ipd: No