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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
  Purpose
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.

Condition Intervention
Irritable Bowel Syndrome Drug: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Discomfort threshold to rectal distension

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 15
Study Start Date: January 2005
Estimated Study Completion Date: July 2005
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314886


Contacts
Contact: Michel Dapoigny, Pr (33) 04 73 75 05 23

Locations
France
Clermont-Ferrand University Hospital Recruiting
Clermont-Ferrand, Auvergne, France, 63000
Contact: Michel Dapoigny, Pr    (33) 04 73 75 05 23      
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Institut National de la Recherche Agronomique
EA 3848 UdA
ERT-CIDAM
Investigators
Principal Investigator: Michel Dapoigny, Pr University Hospital, Clermont-Ferrand
  More Information

Publications:

Responsible Party: Pr Michel Dapoigny, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00314886     History of Changes
Other Study ID Numbers: CHU63-0009
First Submitted: April 13, 2006
First Posted: April 17, 2006
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by University Hospital, Clermont-Ferrand:
Diet
Fiber
Irritable Bowel Syndrome
Colonic Flora

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases