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Sponsors and Collaborators: |
UMC Utrecht Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development Pfizer |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00189033 |
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 |
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Colonic Diseases, Functional |
Drug: psyllium fibre (dietary supplement) Drug: wheat bran (dietary supplement) Drug: rice wheat (placebo) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre? A Randomized Controlled Trial in Primary Care. |
Estimated Enrollment: | 285 |
Study Start Date: | April 2005 |
Study Completion Date: | April 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Department of General Practice | |
Utrecht, Netherlands, 3508 BA | |
University of Maastricht, CAPHRI institute, Department of General Practice | |
Maastricht, Netherlands |
Study Chair: | Prof. A.W. Hoes, M.D., PhD. | University Medical Center Utrecht |
Principal Investigator: | C.J. Bijkerk, M.D. | University Medical Center Utrecht |
Study Director: | N.J. de Wit, MD., PhD. | University Medical Center Utrecht |
Study ID Numbers: | UJ6Z, 4200.0020 |
Study First Received: | September 9, 2005 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00189033 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Irritable Bowel Syndrome Diet Therapy Dietary Fiber Randomized Controlled Trial Family Practice |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Irritable Bowel Syndrome |
Calcium polycarbophil Psyllium Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Syndrome |