<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/NCT03018613</url>
  </required_header>
  <id_info>
    <org_study_id>FMT-CFC</org_study_id>
    <nct_id>NCT03018613</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation for Chronic Functional Constipation</brief_title>
  <acronym>FMTFCFC</acronym>
  <official_title>Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation 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>
      Chronic functional constipation is a common digestive system disease, the incidence is&#xD;
      increasing in recent years.It is reported that the occurrence and development of chronic&#xD;
      functional constipation is closely related to imbalance of intestinal flora .Moreover,types&#xD;
      and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota&#xD;
      transplantation as a new technology to rebuild intestinal flora has been used for several&#xD;
      disease，but the clinical efficacy of chronic functional constipation by fecal microbiota&#xD;
      transplantation needs to be further explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who meet the inclusion crit chronic functional constipation will be separated into&#xD;
      two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood&#xD;
      specimen from patients will be collected to analysis intestinal motility.&#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>Number of adverse events complication rate in all patients in both groups</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean number of bowel movements per week</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bristol stool scale</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constipation-related symptoms assessments</measure>
    <time_frame>4 weeks</time_frame>
    <description>Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usage of laxatives or enemas as rescue medication</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological changes in the intestinal biopsy in both groups.</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitric oxide(NO)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Functional Constipation</condition>
  <condition>Intestinal Bacteria Flora Disturbance</condition>
  <condition>Fecal Microbiota Transplantation</condition>
  <arm_group>
    <arm_group_label>treatment for 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 chronic functional constipation in part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for 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 chronic functional constipation 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 chronic functional constipation in part 1.</description>
    <arm_group_label>treatment for 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 chronic functional constipation in part 2</description>
    <arm_group_label>Placebo for 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 chronic functional constipation in patients;&#xD;
&#xD;
          4. patients has been ruled out organic diseases of the large intestine within 1 year by&#xD;
             colonoscopy or barium enema examination, and stool routine and occult blood&#xD;
             examination are normal within 1 month;&#xD;
&#xD;
          5. be able to communicate well with the researchers and follow the verification&#xD;
             requirements.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. does not meet the diagnostic criteria;&#xD;
&#xD;
          2. with severe primary heart, liver, lung, kidney, blood or affect the survival of&#xD;
             serious diseases;&#xD;
&#xD;
          3. severe anemia and severe systemic infection;&#xD;
&#xD;
          4. suspected or indeed have alcohol, drug abuse history;&#xD;
&#xD;
          5. pregnancy or are preparing for pregnancy, and breastfeeding women;&#xD;
&#xD;
          6. Those who are unwilling to accept the research measures or other reasons can not&#xD;
             cooperate;&#xD;
&#xD;
          7. due to mental disorders can not give adequate informed consent;&#xD;
&#xD;
          8. Participated in other clinical trials within 3 months before the start of the study;&#xD;
&#xD;
          9. researchers believe that participates are not suitable for other reasons in this&#xD;
             clinical trial.&#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 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Functional Constipation</keyword>
  <keyword>Intestinal Bacteria Flora Disturbance</keyword>
  <keyword>Fecal Microbiota Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT03018613
org study id: FMT-CFC
nct id: NCT03018613
lead sponsor: 
has dmc: Yes
Chronic functional constipation is a common digestive system disease, the incidence is
      increasing in recent years.It is reported that the occurrence and development of chronic
      functional constipation is closely related to imbalance of intestinal flora .Moreover,types
      and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota
      transplantation as a new technology to rebuild intestinal flora has been used for several
      disease，but the clinical efficacy of chronic functional constipation by fecal microbiota
      transplantation needs to be further explored.
Patients who meet the inclusion crit chronic functional constipation will be separated into
      two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood
      specimen from patients will be collected to analysis intestinal motility.
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
measure: Mean number of bowel movements per week
time frame: 4 weeks
measure: Bristol stool scale
time frame: 4 weeks
measure: Constipation-related symptoms assessments
time frame: 4 weeks
description: Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4.
measure: Usage of laxatives or enemas as rescue medication
time frame: 4 weeks
measure: Histological changes in the intestinal biopsy in both groups.
time frame: 4 weeks
measure: Microbiota composition
time frame: 4 weeks
measure: Nitric oxide(NO)
time frame: 4 weeks
arm group label: treatment for part 1
arm group type: Active Comparator
description: Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.
arm group label: Placebo for part 2
arm group type: Placebo Comparator
description: The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines.
intervention type: Other
intervention name: Fecal Microbiota Transplantation
description: Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
arm group label: treatment for part 1
other name: Fecal Microbiota Transplantation(FMT)
intervention type: Other
intervention name: Normal Saline
description: Normal saline and the traditional treatments for chronic functional constipation in part 2
arm group label: Placebo for 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: Constipation
mesh term: Dysbiosis
sharing ipd: No