Clinical Effects of Soluble Dietary Fiber Supplementation

Phase 3

Completed

• Conditions: Hypomotility; Constipation
• Interventions: Drug: Pectin

• Registration Number: NCT02194972
• Lead Sponsor: Nanjing PLA General Hospital

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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-21
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• Mental disorders
• Cancer
• Inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
soluble dietary fiber	Pectin	pectin, a kind of soluble dietary fiber

Primary Outcome Measures

Name	Time	Method
efficacy: intestinal transit time	four weeks after inclusion	colonic transit time

Secondary Outcome Measures

Name	Time	Method
efficacy: gut microbiota	four weeks after inclusion	real-time PCR
efficacy: clinical symptoms	four weeks after inclusion	Wexner constipation score