NCT00189033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

September 9, 2005

Last Update Submit

April 19, 2007

Conditions

Colonic Diseases, Functional

Keywords

Irritable Bowel SyndromeDiet TherapyDietary FiberRandomized Controlled TrialFamily Practice

Outcome Measures

Primary Outcomes (1)

  • Adequate Relief of abdominal pain or discomfort.

Secondary Outcomes (4)

  • IBS symptoms (IBS symptom severity score)

  • IBS related quality of life (IBSQOL)

  • Fibre intake

  • The number of doctor visits and costs

Interventions

psyllium fibre (dietary supplement)DRUG
wheat bran (dietary supplement)DRUG
rice wheat (placebo)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maastricht, CAPHRI institute, Department of General Practice

Maastricht, Netherlands

Location

University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Department of General Practice

Utrecht, 3508 BA, Netherlands

Location

Related Publications (1)

  • Bijkerk CJ, de Wit NJ, Muris JW, Whorwell PJ, Knottnerus JA, Hoes AW. Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial. BMJ. 2009 Aug 27;339:b3154. doi: 10.1136/bmj.b3154.

    PMID: 19713235DERIVED

MeSH Terms

Conditions

Colonic Diseases, FunctionalIrritable Bowel Syndrome

Interventions

Dietary SupplementsDietary Fiber

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary CarbohydratesCarbohydrates

Study Officials

  • Prof. A.W. Hoes, M.D., PhD.

    UMC Utrecht

    STUDY CHAIR

  • C.J. Bijkerk, M.D.

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • N.J. de Wit, MD., PhD.

    UMC Utrecht

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

April 1, 2005

Study Completion

April 1, 2007

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

NL(2)