Clinical Effects of Soluble Dietary Fiber Supplementation

August 22, 2018 updated by: Gao Tao, Nanjing PLA General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: soluble dietary fiber
pectin, a kind of soluble dietary fiber
Drug: Pectin
pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks
Other Names:
  • soluble dietary fiber
NO_INTERVENTION: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy: intestinal transit time
Time Frame: four weeks after inclusion
colonic transit time
four weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy: clinical symptoms
Time Frame: four weeks after inclusion
Wexner constipation score
four weeks after inclusion
efficacy: gut microbiota
Time Frame: four weeks after inclusion
real-time PCR
four weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (ESTIMATE)

July 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011NLY42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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