drugset / Trial / NCT00189033

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

NCT00189033

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-04
Primary completion
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PLANTAGO SEED Other / unclassified 10 g Oral
Subject wheat bran Unknown 10 g Oral