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Effect of Butyrogenic Fibers in IBS Patients

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT00314886
CHU63-0009

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Michel Dapoigny, Pr

Data sourced from clinicaltrials.gov

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