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

This study has been completed.

First Received on September 9, 2005. Last Updated on April 19, 2007 History of Changes

Sponsor:	UMC Utrecht
Collaborators:	Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development Pfizer
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00189033

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:

MedlinePlus related topics: Abdominal Pain Colonic Diseases Dietary Fiber Dietary Supplements Irritable Bowel Syndrome

Drug Information available for: Psyllium Calcium polycarbophil

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):

Bijkerk CJ, de Wit NJ, Muris JW, Whorwell PJ, Knottnerus JA, Hoes AW. Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial. BMJ. 2009 Aug 27;339:b3154.

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 February 09, 2012