<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/NCT02194972</url>
  </required_header>
  <id_info>
    <org_study_id>2011NLY42</org_study_id>
    <nct_id>NCT02194972</nct_id>
  </id_info>
  <brief_title>Clinical Effects of Soluble Dietary Fiber Supplementation</brief_title>
  <official_title>Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing PLA General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary&#xD;
      fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with&#xD;
      slow-transit constipation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks&#xD;
      supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time,&#xD;
      constipation symptoms and fecal bacterial population in two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy: intestinal transit time</measure>
    <time_frame>four weeks after inclusion</time_frame>
    <description>colonic transit time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>efficacy: clinical symptoms</measure>
    <time_frame>four weeks after inclusion</time_frame>
    <description>Wexner constipation score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>efficacy: gut microbiota</measure>
    <time_frame>four weeks after inclusion</time_frame>
    <description>real-time PCR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Hypomotility</condition>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>soluble dietary fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pectin, a kind of soluble dietary fiber</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pectin</intervention_name>
    <description>pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks</description>
    <arm_group_label>soluble dietary fiber</arm_group_label>
    <other_name>soluble dietary fiber</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients(age≧18y)&#xD;
&#xD;
          -  Admitted for slow-transit constipation were considered eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental disorders&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tao Gao, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing PLA General Hospital</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>August 22, 2018</last_update_submitted>
  <last_update_submitted_qc>August 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Gao Tao</investigator_full_name>
    <investigator_title>Nanjing PLA General Hospital</investigator_title>
  </responsible_party>
  <keyword>constipation</keyword>
  <keyword>colon transit time</keyword>
  <keyword>gut microbiota</keyword>
  <keyword>soluble dietary fiber</keyword>
  <keyword>disturbance of gut microbiota in constipation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT02194972
org study id: 2011NLY42
nct id: NCT02194972
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary
      fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with
      slow-transit constipation.
Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks
      supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time,
      constipation symptoms and fecal bacterial population in two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: efficacy: intestinal transit time
time frame: four weeks after inclusion
description: colonic transit time
measure: efficacy: clinical symptoms
time frame: four weeks after inclusion
description: Wexner constipation score
measure: efficacy: gut microbiota
time frame: four weeks after inclusion
description: real-time PCR
arm group label: soluble dietary fiber
arm group type: Experimental
description: pectin, a kind of soluble dietary fiber
arm group label: Placebo
arm group type: No Intervention
description: Placebo
intervention type: Drug
intervention name: Pectin
description: pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks
arm group label: soluble dietary fiber
other name: soluble dietary fiber
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: No
last name: Tao Gao, M.D.
role: Principal Investigator
affiliation: Nanjing PLA General Hospital
responsible party type: Principal Investigator
investigator affiliation: Nanjing PLA General Hospital
investigator full name: Gao Tao
investigator title: Nanjing PLA General Hospital
mesh term: Constipation