NCT02234518

Fibers and Gut Health

Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Fiber Containing Product in Adults With Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Gastrointestinal discomfort regularly affects \>25% of the population worldwide. One of the major contributors to GI discomfort is constipation, which has a prevalence of \~15% and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel. Dietary fiber supplements are widely used as a first-line treatment for constipation although little Level 1 evidence exists to support its use in adults. The effectiveness of different fiber supplements is difficult to compare given wide differences in water-retention capabilities and effects on the colonic microbial ecology. Given the promising, yet largely unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation, the objective of this clinical trial is to evaluate tolerance and effectiveness of four week supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.

Conditions

• Constipation

Interventions

Type	Name	Description
OTHER	High quantity fiber	The intervention type is food product
OTHER	Low quantity fiber	The intervention type is food product
OTHER	Placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-09-09
• Last updated: 2015-11-10

Locations

1 site across 1 country: Netherlands