Effect of Butyrogenic Fibers in IBS Patients

NCT ID: NCT00314886

Last Updated: 2011-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Diet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role collaborator

EA 3848 UdA

UNKNOWN

Sponsor Role collaborator

ERT: Clinical Trial Technology Solutions

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Michel Dapoigny, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Michel Dapoigny, Pr

Role: CONTACT

(33) 04 73 75 05 23

Facility Contacts

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Michel Dapoigny, Pr

Role: primary

(33) 04 73 75 05 23

References

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Dunlop SP, Spiller RC. Nutritional issues in irritable bowel syndrome. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):537-40. doi: 10.1097/00075197-200111000-00013.

Reference Type BACKGROUND
PMID: 11706290 (View on PubMed)

Francis CY, Whorwell PJ. Bran and irritable bowel syndrome: time for reappraisal. Lancet. 1994 Jul 2;344(8914):39-40. doi: 10.1016/s0140-6736(94)91055-3.

Reference Type BACKGROUND
PMID: 7912305 (View on PubMed)

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. doi: 10.1128/AEM.68.6.2982-2990.2002.

Reference Type BACKGROUND
PMID: 12039758 (View on PubMed)

Jones R, Lydeard S. Irritable bowel syndrome in the general population. BMJ. 1992 Jan 11;304(6819):87-90. doi: 10.1136/bmj.304.6819.87.

Reference Type BACKGROUND
PMID: 1737146 (View on PubMed)

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. doi: 10.1016/s0140-6736(82)92782-9.

Reference Type BACKGROUND
PMID: 6128447 (View on PubMed)

King TS, Elia M, Hunter JO. Abnormal colonic fermentation in irritable bowel syndrome. Lancet. 1998 Oct 10;352(9135):1187-9. doi: 10.1016/s0140-6736(98)02146-1.

Reference Type BACKGROUND
PMID: 9777836 (View on PubMed)

Snook J, Shepherd HA. Bran supplementation in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 1994 Oct;8(5):511-4. doi: 10.1111/j.1365-2036.1994.tb00323.x.

Reference Type BACKGROUND
PMID: 7865643 (View on PubMed)

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. doi: 10.1016/s0304-3959(02)00234-8.

Reference Type BACKGROUND
PMID: 12435462 (View on PubMed)

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. doi: 10.1053/j.gastro.2005.03.082.

Reference Type BACKGROUND
PMID: 15940632 (View on PubMed)

Other Identifiers

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CHU63-0009

Identifier Type: -

Identifier Source: org_study_id

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