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Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

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

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Gut microbiota, Soluble dietary fiber

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients(age≧18y)
  • Admitted for diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    pectin

    Placebo

    Arm Description

    a kind of soluble dietary fiber

    maltodextrin

    Outcomes

    Primary Outcome Measures

    efficacy: change of stool frequency, faecal form and clinical symptoms score
    change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks

    Secondary Outcome Measures

    efficacy: gut microbiota
    real-time PCR
    efficacy: cytokine ratios
    Cytokine production

    Full Information

    First Posted
    October 10, 2014
    Last Updated
    March 23, 2016
    Sponsor
    Nanjing PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02270268
    Brief Title
    Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
    Official Title
    Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2013 (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 clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome
    Detailed Description
    Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome
    Keywords
    Irritable bowel syndrome, Gut microbiota, Soluble dietary fiber

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    pectin
    Arm Type
    Experimental
    Arm Description
    a kind of soluble dietary fiber
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    maltodextrin
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Pectin
    Intervention Description
    Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    maltodextrin
    Primary Outcome Measure Information:
    Title
    efficacy: change of stool frequency, faecal form and clinical symptoms score
    Description
    change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks
    Time Frame
    six weeks after inclusion
    Secondary Outcome Measure Information:
    Title
    efficacy: gut microbiota
    Description
    real-time PCR
    Time Frame
    six weeks after inclusion
    Title
    efficacy: cytokine ratios
    Description
    Cytokine production
    Time Frame
    six weeks after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients(age≧18y) Admitted for diarrhea-predominant irritable bowel syndrome 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

    Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome

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