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Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre?

NCT00189033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2007-04-20

No results posted yet for this study

Summary

The purpose of this study is to assess the role of dietary fibre in Irritable Bowel Syndrome (IBS) treatment, in particular the role of increasing the content of soluble or insoluble fibres in the daily diet. The primary objective is to compare soluble (psyllium) and insoluble (bran) to placebo, administered over 12 weeks in patients with 'probable' or 'definite' Irritable Bowel Syndrome. The primary efficacy parameter is the responder rate based on weekly assessment of adequate relief of IBS symptoms. Secondary efficacy parameters include changes in IBS related symptoms (abdominal pain, bowel habits) and quality of life.

Conditions

  • Colonic Diseases, Functional

Interventions

DRUG

psyllium fibre (dietary supplement)

DRUG

wheat bran (dietary supplement)

DRUG

rice wheat (placebo)

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Prof. A.W. Hoes, M.D., PhD. · UMC Utrecht

  • C.J. Bijkerk, M.D. · UMC Utrecht

  • N.J. de Wit, MD., PhD. · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-04-30
Completion
2007-04-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT00189033 on ClinicalTrials.gov