Effect of Butyrogenic Fibers in IBS Patients

Not Applicable

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00314886
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.

Detailed Description

Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.

Study Timeline

• Study Start: 2005-01
• Study Completion: 2005-07
• Study First Submitted: 2006-04-13
• Study First Submitted QC: 2006-04-14
• Study First Posted: 2006-04-17
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Female aged 18-60 years
• Normal volunteers and patients with IBS assessed by Rome II criteria
• Effective contraception
• Affiliated to National Health Service
• Having received oral and written information about the study
• Having provided her written informed consent

Exclusion Criteria

• Significant clinical or biological abnormality
• Organic gastrointestinal disease
• Subjects having lower than 15g/day or higher than 20g/day fibres intake
• Antibiotic treatment during the month preceding the pre inclusion day
• Antispasmodics, antidiarrheics, laxatives, and prokinetics during the week preceding the pre inclusion day and during all the study period.
• Digestive surgery tract except appendectomy and cholecystectomy
• Alcohol abuse
• Drug addiction
• Major psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Discomfort threshold to rectal distension

Secondary Outcome Measures

Name	Time	Method
Intestinal discomfort (questionnaire)
Quality of life (questionnaire)
Functional composition of colonic flora
Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
Taxonomic composition of colonic flora
Fermentation profile of ingested fibre

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Auvergne, France