Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre?
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
UMC Utrecht
Collaborators:
Maastricht University Medical Center Pfizer ZonMw: The Netherlands Organisation for Health Research and Development