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Effect of Butyrogenic Fibers in IBS Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314886
First Posted: April 17, 2006
Last Update Posted: January 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Institut National de la Recherche Agronomique
EA 3848 UdA
ERT-CIDAM
Information provided by:
University Hospital, Clermont-Ferrand
April 13, 2006
April 17, 2006
January 19, 2011
January 2005
Not Provided
Discomfort threshold to rectal distension
Same as current
Complete list of historical versions of study NCT00314886 on ClinicalTrials.gov Archive Site
  • 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
  • Fermentation profile of ingested fibre
Same as current
Not Provided
Not Provided
 
Effect of Butyrogenic Fibers in IBS Patients
Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome
Drug: Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
July 2005
Not Provided

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
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00314886
CHU63-0009
Not Provided
Not Provided
Not Provided
Pr Michel Dapoigny, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • Institut National de la Recherche Agronomique
  • EA 3848 UdA
  • ERT-CIDAM
Principal Investigator: Michel Dapoigny, Pr University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP