Status:
COMPLETED
Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre?
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Colonic Diseases, Functional
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 dai...
Detailed Description
INTRODUCTION: In daily practice, both patients and doctors consider dietary factors, especially fibre and fluid intake, to play an important role in both the aetiology and the persistence of Irritable...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00189033
Start Date
April 1 2005
End Date
April 1 2007
Last Update
April 20 2007
Active Locations (2)
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1
University of Maastricht, CAPHRI institute, Department of General Practice
Maastricht, Netherlands
2
University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Department of General Practice
Utrecht, Netherlands, 3508 BA