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OpenTrials
Completed

NCT Number: NCT02270268

Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease

Treatment and study plan

Pectin

Dietary Supplement

Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks

Maltodextrin

Dietary Supplement

Primary outcomes

  1. efficacy: change of stool frequency, faecal form and clinical symptoms score

    Time frame: six weeks after inclusion

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

Secondary outcomes

  1. efficacy: gut microbiota

    Time frame: six weeks after inclusion

    real-time PCR

  2. efficacy: cytokine ratios

    Time frame: six weeks after inclusion

    Cytokine production

Sponsors and collaborators

Lead sponsor

Nanjing PLA General Hospital

Other

Registry information

Official study title

Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 21, 2014
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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