<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/NCT03233100</url>
  </required_header>
  <id_info>
    <org_study_id>STC-D-A-2017-FMT</org_study_id>
    <nct_id>NCT03233100</nct_id>
  </id_info>
  <brief_title>FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms</brief_title>
  <official_title>FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jianfeng Gong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</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>
      Constipated patients often have mental problems such as depression and anxiety due to&#xD;
      difficult defecation. Our previous studies have proved the efficacy of FMT treating&#xD;
      constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota.&#xD;
      This trial is based on the theory of the gut-brain-microbiota axis. Patients with&#xD;
      constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota&#xD;
      examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the&#xD;
      potential role of gut microbiome in these gut-brain disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 30, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CSBMs per week</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>complete spontaneous bowl movements per week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HAMA</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>score of Hamilton Anxiety Rating Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HAMD</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>score of Hamilton Depression Rating Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wexner</measure>
    <time_frame>pre, 2 weeks, 4 weeks, 8 weeks, 12weeks</time_frame>
    <description>score of Wexner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAC-SYM</measure>
    <time_frame>pre, 2 weeks, 4 weeks, 8 weeks, 12weeks</time_frame>
    <description>score of PAC-SYM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bristol Bristol PAC-SYM</measure>
    <time_frame>pre, 2 weeks, 4 weeks, 8 weeks, 12weeks</time_frame>
    <description>score of Bristol score of Bristol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAC-QOL</measure>
    <time_frame>pre, 2 weeks, 4 weeks, 8 weeks, 12weeks</time_frame>
    <description>score of PAC-QOL</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Gut microbiota analysis</measure>
    <time_frame>pre, 4 weeks, 12 weeks</time_frame>
    <description>Gut microbiota analysis</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Constipation - Functional</condition>
  <condition>Depressive Symptoms</condition>
  <condition>Anxiety Symptoms</condition>
  <condition>Gut-Brain Disorders</condition>
  <arm_group>
    <arm_group_label>FMT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FMT</intervention_name>
    <description>fecal microbiota transplantation</description>
    <arm_group_label>FMT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were diagnosed as functional constipation (FC) according to Rome Ⅳ&#xD;
             criteria were enrolled.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Body mass index of 18-25 kg/m2.&#xD;
&#xD;
          -  HAMA ≥ 14 and/or HAMD (17 items) ≥ 17&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of sever mental disorders such as schizophrenia and bipolar disorder&#xD;
&#xD;
          -  History of organic intestinal disorders&#xD;
&#xD;
          -  History of gastrointestinal surgery&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Infection with enteric pathogen&#xD;
&#xD;
          -  Usage of probiotics, prebiotics, antibiotics within the last month&#xD;
&#xD;
          -  Uncontrolled hepatic, renal, cardiovascular, and respiratory, or any diseases that in&#xD;
             the opinion of the investigator, could affect intestinal transit and the intestinal&#xD;
             microbiota.&#xD;
&#xD;
          -  Patients who could not complete the follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianfeng Gong, MD</last_name>
    <phone>+86-25-80860036</phone>
    <email>gongjianfeng@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianfeng Gong, MD</last_name>
      <phone>+86-25-80860036</phone>
      <email>gongjianfeng@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Jianfeng Gong</investigator_full_name>
    <investigator_title>Professor, Associate senior doctor</investigator_title>
  </responsible_party>
  <keyword>FMT</keyword>
  <keyword>gut microbiota</keyword>
  <keyword>gut-brain disorder</keyword>
  <keyword>constipation</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Constipation</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Anxiety Disorders</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/NCT03233100
org study id: STC-D-A-2017-FMT
nct id: NCT03233100
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Constipated patients often have mental problems such as depression and anxiety due to
      difficult defecation. Our previous studies have proved the efficacy of FMT treating
      constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota.
      This trial is based on the theory of the gut-brain-microbiota axis. Patients with
      constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota
      examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the
      potential role of gut microbiome in these gut-brain disorders.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: CSBMs per week
time frame: 12 weeks after treatment
description: complete spontaneous bowl movements per week
measure: HAMA
time frame: 12 weeks after treatment
description: score of Hamilton Anxiety Rating Scale
measure: HAMD
time frame: 12 weeks after treatment
description: score of Hamilton Depression Rating Scale
measure: Wexner
time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
description: score of Wexner
measure: PAC-SYM
time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
description: score of PAC-SYM
measure: Bristol Bristol PAC-SYM
time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
description: score of Bristol score of Bristol
measure: PAC-QOL
time frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
description: score of PAC-QOL
measure: Gut microbiota analysis
time frame: pre, 4 weeks, 12 weeks
description: Gut microbiota analysis
arm group label: FMT group
arm group type: Experimental
intervention type: Other
intervention name: FMT
description: fecal microbiota transplantation
arm group label: FMT group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jianfeng Gong, MD
phone: +86-25-80860036
email: gongjianfeng@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Jianfeng Gong
investigator title: Professor, Associate senior doctor
mesh term: Brain Diseases
mesh term: Constipation
mesh term: Depression
mesh term: Anxiety Disorders