Effect of Butyrogenic Fibers in IBS Patients

Irritable Bowel Syndrome Clinical Trial

Official title:

Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00314886
• Other study ID #: CHU63-0009
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2006
• Last updated: January 18, 2011
• Start date: January 2005
• Est. completion date: July 2005

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Michel Dapoigny, Pr
• Phone: (33) 04 73 75 05 23
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• Diet

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Auvergne

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	EA 3848 UdA, ERT-CIDAM, Institut National de la Recherche Agronomique

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

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

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

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort threshold to rectal distension
Secondary	Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
Secondary	Intestinal discomfort (questionnaire)
Secondary	Quality of life (questionnaire)
Secondary	Taxonomic composition of colonic flora
Secondary	Functional composition of colonic flora
Secondary	Fermentation profile of ingested fibre