Effect of Butyrogenic Fibers in IBS Patients - Full Text View

Purpose

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.

Condition	Intervention
Irritable Bowel Syndrome	Drug: Diet

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fiber

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Discomfort threshold to rectal distension

Secondary Outcome Measures:

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

Estimated Enrollment:	15
Study Start Date:	January 2005
Estimated Study Completion Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314886

Contacts

Contact: Michel Dapoigny, Pr

(33) 04 73 75 05 23

Locations

France
Clermont-Ferrand University Hospital	Recruiting
Clermont-Ferrand, Auvergne, France, 63000
Contact: Michel Dapoigny, Pr (33) 04 73 75 05 23

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Institut National de la Recherche Agronomique

EA 3848 UdA

ERT-CIDAM

Investigators

Principal Investigator:

Michel Dapoigny, Pr

University Hospital, Clermont-Ferrand

More Information

Publications:

Dunlop SP, Spiller RC. Nutritional issues in irritable bowel syndrome. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):537-40. Review.

Francis CY, Whorwell PJ. Bran and irritable bowel syndrome: time for reappraisal. Lancet. 1994 Jul 2;344(8914):39-40.

Harmsen HJ, Raangs GC, He T, Degener JE, Welling GW. Extensive set of 16S rRNA-based probes for detection of bacteria in human feces. Appl Environ Microbiol. 2002 Jun;68(6):2982-90.

Jones R, Lydeard S. Irritable bowel syndrome in the general population. BMJ. 1992 Jan 11;304(6819):87-90.

Jones VA, McLaughlan P, Shorthouse M, Workman E, Hunter JO. Food intolerance: a major factor in the pathogenesis of irritable bowel syndrome. Lancet. 1982 Nov 20;2(8308):1115-7.

King TS, Elia M, Hunter JO. Abnormal colonic fermentation in irritable bowel syndrome. Lancet. 1998 Oct 10;352(9135):1187-9.

Snook J, Shepherd HA. Bran supplementation in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 1994 Oct;8(5):511-4.

Tarrerias AL, Millecamps M, Alloui A, Beaughard C, Kemeny JL, Bourdu S, Bommelaer G, Eschalier A, Dapoigny M, Ardid D. Short-chain fatty acid enemas fail to decrease colonic hypersensitivity and inflammation in TNBS-induced colonic inflammation in rats. Pain. 2002 Nov;100(1-2):91-7.

Bourdu S, Dapoigny M, Chapuy E, Artigue F, Vasson MP, Dechelotte P, Bommelaer G, Eschalier A, Ardid D. Rectal instillation of butyrate provides a novel clinically relevant model of noninflammatory colonic hypersensitivity in rats. Gastroenterology. 2005 Jun;128(7):1996-2008.

Responsible Party:	Pr Michel Dapoigny, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00314886 History of Changes
Other Study ID Numbers:	CHU63-0009
Study First Received:	April 13, 2006
Last Updated:	January 18, 2011
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Diet
Fiber
Irritable Bowel Syndrome
Colonic Flora

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013