Effect of Butyrogenic Fibers in IBS Patients
Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2005
Shorter than P25 for not_applicable
1 active site
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
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 13, 2006
CompletedFirst Posted
Study publicly available on registry
April 17, 2006
CompletedJanuary 19, 2011
January 1, 2011
April 13, 2006
January 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Discomfort threshold to rectal distension
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant clinical or biological abnormality
- Organic gastrointestinal disease
- Subjects having lower than 15g/day or higher than 20g/day fibres intake
- Digestive surgery tract except appendectomy and cholecystectomy
- Alcohol abuse
- Drug addiction
- Major psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63000, France
Related Publications (9)
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.
PMID: 11706290BACKGROUNDFrancis 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.
PMID: 7912305BACKGROUNDHarmsen 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.
PMID: 12039758BACKGROUNDJones 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.
PMID: 1737146BACKGROUNDJones 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.
PMID: 6128447BACKGROUNDKing 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.
PMID: 9777836BACKGROUNDSnook 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.
PMID: 7865643BACKGROUNDTarrerias 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.
PMID: 12435462BACKGROUNDBourdu 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.
PMID: 15940632BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Dapoigny, Pr
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 13, 2006
First Posted
April 17, 2006
Study Start
January 1, 2005
Study Completion
July 1, 2005
Last Updated
January 19, 2011
Record last verified: 2011-01