Clinical Effects of Soluble Dietary Fiber Supplementation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194972
• Other study ID #: 2011NLY42
• Status: Completed
• Phase: Phase 3
• Start date: May 2009
• Est. completion date: October 2012

Study information

• Verified date: July 2014
• Source: Nanjing PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• All patients(age?18y)

• Admitted for slow-transit constipation were considered eligible

Exclusion Criteria:

• Mental disorders

• Cancer

• Inflammatory bowel disease

Related Conditions & MeSH terms

• Constipation
• Hypomotility

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy: intestinal transit time	colonic transit time	four weeks after inclusion
Secondary	efficacy: clinical symptoms	Wexner constipation score	four weeks after inclusion
Secondary	efficacy: gut microbiota	real-time PCR	four weeks after inclusion