Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Discomfort threshold to rectal distension
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Discomfort threshold to rectal distension
Secondary Outcomes
- Quality of life (questionnaire)
- Functional composition of colonic flora
- Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
- Taxonomic composition of colonic flora
- Fermentation profile of ingested fibre
- Intestinal discomfort (questionnaire)