Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre?
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.
Colonic Diseases, Functional
Drug: psyllium fibre (dietary supplement)
Drug: wheat bran (dietary supplement)
Drug: rice wheat (placebo)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre? A Randomized Controlled Trial in Primary Care.|
- Adequate Relief of abdominal pain or discomfort.
- IBS symptoms (IBS symptom severity score)
- IBS related quality of life (IBSQOL)
- Fibre intake
- The number of doctor visits and costs
|Study Start Date:||April 2005|
|Study Completion Date:||April 2007|
|University of Maastricht, CAPHRI institute, Department of General Practice|
|University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Department of General Practice|
|Utrecht, Netherlands, 3508 BA|
|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|