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

This study has been completed.
Sponsor:
Collaborators:
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Pfizer
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189033
First received: September 9, 2005
Last updated: April 19, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
Colonic Diseases, Functional
 Drug: psyllium fibre (dietary supplement)
Drug: wheat bran (dietary supplement)
Drug: rice wheat (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre? A Randomized Controlled Trial in Primary Care.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Adequate Relief of abdominal pain or discomfort.

Secondary Outcome Measures:
  • IBS symptoms (IBS symptom severity score)
  • IBS related quality of life (IBSQOL)
  • Fibre intake
  • The number of doctor visits and costs

Estimated Enrollment: 285
Study Start Date: April 2005
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-65 years presenting to their General Practitioner (GP) with either incident IBS symptoms or with a relapse of pre-existing IBS as well as patients with a prior GP diagnosis of IBS and currently experiencing symptoms are eligible for the study. Patients will be stratified in two equally large patients groups of (a) 'definite' IBS, according to the Rome II diagnostic criteria, and (b) 'probable' IBS, pragmatically diagnosed with IBS by their GP.

Exclusion Criteria:

  • Patients treated with fibre in the prior 4 weeks
  • Patients with alarm symptoms i.e. abnormalities at physical examination, fever, weight loss, rectal bleeding, acute abdominal pain
  • Patient with fibre intolerance
  • Patients treated for Irritable Bowel Syndrome by a specialist in the prior 48 months
  • Patients with active psychiatric disorder requiring medication
  • Patients not able to fill out the questionnaires
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189033

Locations
Netherlands
University of Maastricht, CAPHRI institute, Department of General Practice
Maastricht, Netherlands
University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Department of General Practice
Utrecht, Netherlands, 3508 BA
Sponsors and Collaborators
UMC Utrecht
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Pfizer
Investigators
Study Chair: Prof. A.W. Hoes, M.D., PhD. UMC Utrecht
Principal Investigator: C.J. Bijkerk, M.D. UMC Utrecht
Study Director: N.J. de Wit, MD., PhD. UMC Utrecht
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00189033     History of Changes
Other Study ID Numbers: UJ6Z, 4200.0020
Study First Received: September 9, 2005
Last Updated: April 19, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Irritable Bowel Syndrome
Diet Therapy
Dietary Fiber
Randomized Controlled Trial
Family Practice

Additional relevant MeSH terms:
Colonic Diseases
Colonic Diseases, Functional
Irritable Bowel Syndrome
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Psyllium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013