Fructo-oligosaccharides and Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Beghin-Meiji
ClinicalTrials.gov Identifier:
NCT00806104
First received: December 9, 2008
Last updated: January 14, 2011
Last verified: January 2011
  Purpose

Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.


Condition Intervention
Irritable Bowel Syndrome
Dietary Supplement: Fructo-oligosaccharides
Dietary Supplement: Maltodextrins

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients

Further study details as provided by Beghin-Meiji:

Primary Outcome Measures:
  • rectal sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • taxonomic composition of intestinal microbiota [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fructo-oligosaccharides
Dietary Supplement: Fructo-oligosaccharides
Dietary supplementation for 4 weeks
Placebo Comparator: 2
Maltodextrins
Dietary Supplement: Maltodextrins
Dietary supplementation for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • IBS subjects according to Rome III criteria
  • Incomfort below or equivalent to 30mmHg during Tensostat test
  • between 18 and 60 years
  • no antibiotic treatment for the last 2 months
  • less than 20g of dietary fibres consummed per day
  • no analgesic treatment
  • no treatment for intestinal transit

Exclusion Criteria:

  • subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
  • excessive consumption of alcohol or tobacco
  • participating to another clinical study
  • pregnant women
  • antidepressor or anxiolytic treatment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806104

Locations
France
CHU Clermont Ferrand
Clermont-Ferrand, France, 63003
Spain
Vall Hebron Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Beghin-Meiji
Investigators
Principal Investigator: Michel Dapoigny, MD, PhD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Frederique Respondek / Scientific Affairs Manager, Beghin Meiji
ClinicalTrials.gov Identifier: NCT00806104     History of Changes
Other Study ID Numbers: FOS_QLV2
Study First Received: December 9, 2008
Last Updated: January 14, 2011
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014