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Fibers and Gut Health

NCT02234518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-11-10

No results posted yet for this study

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

Interventions

OTHER

High quantity fiber

The intervention type is food product

OTHER

Low quantity fiber

The intervention type is food product

OTHER

Placebo

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Diederick E. Grobbee, Prof, MD, PhD · Julius Clinical

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234518 on ClinicalTrials.gov