Clinical Effects of Soluble Dietary Fiber Supplementation

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.

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Key information

Conditions

Hypomotility Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–78 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 4 weeks supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time, constipation symptoms and fecal bacterial population 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 slow-transit constipation were considered eligible

Exclusion criteria

Mental disorders
Cancer
Inflammatory bowel disease

Treatment and study plan

Pectin

Drug

pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks

Other names: soluble dietary fiber

Primary outcomes

efficacy: intestinal transit time

Time frame: four weeks after inclusion

colonic transit time

Secondary outcomes

efficacy: clinical symptoms

Time frame: four weeks after inclusion

Wexner constipation score
efficacy: gut microbiota

Time frame: four weeks after inclusion

real-time PCR

Sponsors and collaborators

Lead sponsor

Nanjing PLA General Hospital

Other

Registry information

Official study title

Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jul 21, 2014
Registry last updated: Aug 24, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed