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Clinical Effects of Soluble Dietary Fiber Supplementation

Primary Purpose

Hypomotility, Constipation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pectin
Sponsored by
Nanjing PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypomotility focused on measuring constipation, colon transit time, gut microbiota, soluble dietary fiber, disturbance of gut microbiota in constipation

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients(age≧18y)
  • Admitted for slow-transit constipation were considered eligible

Exclusion Criteria:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    soluble dietary fiber

    Placebo

    Arm Description

    pectin, a kind of soluble dietary fiber

    Placebo

    Outcomes

    Primary Outcome Measures

    efficacy: intestinal transit time
    colonic transit time

    Secondary Outcome Measures

    efficacy: clinical symptoms
    Wexner constipation score
    efficacy: gut microbiota
    real-time PCR

    Full Information

    First Posted
    July 17, 2014
    Last Updated
    August 22, 2018
    Sponsor
    Nanjing PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02194972
    Brief Title
    Clinical Effects of Soluble Dietary Fiber Supplementation
    Official Title
    Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing PLA General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypomotility, Constipation
    Keywords
    constipation, colon transit time, gut microbiota, soluble dietary fiber, disturbance of gut microbiota in constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    soluble dietary fiber
    Arm Type
    Experimental
    Arm Description
    pectin, a kind of soluble dietary fiber
    Arm Title
    Placebo
    Arm Type
    No Intervention
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Pectin
    Other Intervention Name(s)
    soluble dietary fiber
    Intervention Description
    pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks
    Primary Outcome Measure Information:
    Title
    efficacy: intestinal transit time
    Description
    colonic transit time
    Time Frame
    four weeks after inclusion
    Secondary Outcome Measure Information:
    Title
    efficacy: clinical symptoms
    Description
    Wexner constipation score
    Time Frame
    four weeks after inclusion
    Title
    efficacy: gut microbiota
    Description
    real-time PCR
    Time Frame
    four weeks after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients(age≧18y) Admitted for slow-transit constipation were considered eligible Exclusion Criteria: Mental disorders Cancer Inflammatory bowel disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tao Gao, M.D.
    Organizational Affiliation
    Nanjing PLA General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Effects of Soluble Dietary Fiber Supplementation

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