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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: Maastricht University Medical Center; Pfizer; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Psyllium

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