Clinical trial NCT00314886: Effect of Butyrogenic Fibers in IBS Patients
Official title: Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Diet
Fiber
Irritable Bowel Syndrome
Colonic Flora
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: EA 3848 UdA
name: ERT: Clinical Trial Technology Solutions
First posted: 2006-04-17
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Discomfort threshold to rectal distension
Secondary outcomes:
measure: Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
measure: Intestinal discomfort (questionnaire)
measure: Quality of life (questionnaire)
measure: Taxonomic composition of colonic flora
measure: Functional composition of colonic flora
measure: Fermentation profile of ingested fibre
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Michel Dapoigny, Pr
role: PRINCIPAL_INVESTIGATOR
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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. doi: 10.1016/s0304-3959(02)00234-8.
citation: 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.