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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre? A Randomized Controlled Trial in Primary Care.

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 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.

Detailed Summary:

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 Bowel Syndrome (IBS) symptoms. The majority of doctors provides dietary lifestyle advice, targeted at increasing the fibre content of the daily diet by adding insoluble fibre. In addition more than 50% of IBS patients receive pharmacotherapy, frequently including bulking agents, in particular soluble fibres such as psyllium-supplements. There is, however, limited evidence that fibre therapy may alleviate IBS symptoms. In addition, there are indications that insoluble fibres may even worsen IBS symptoms. Scientific evidence pertaining to the different effects of soluble and insoluble fibres on IBS symptoms is very limited indeed, and methodologically sound RCTs in primary care patients are lacking altogether. The latter is important since primary care IBS patients differ in many aspects from secondary/tertiary care patients.

STUDY DESIGN: A double blind parallel-group randomised controlled trial involving IBS patients in primary care comparing 12-week intervention of psyllium fibres, bran, and placebo. After the intervention, all patients will be followed for an additional 12-week period.

STUDY POPULATION: 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. Patients with alarm symptoms (i.e. abnormalities at physical exam
Sponsor: UMC Utrecht

Current Primary Outcome: Adequate Relief of abdominal pain or discomfort.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • IBS symptoms (IBS symptom severity score)
  • IBS related quality of life (IBSQOL)
  • Fibre intake
  • The number of doctor visits and costs


Original Secondary Outcome: Same as current

Information By: UMC Utrecht

Dates:
Date Received: September 9, 2005
Date Started: April 2005
Date Completion:
Last Updated: April 19, 2007
Last Verified: April 2007