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

December 9, 2008
January 14, 2011
March 2009
July 2010   (final data collection date for primary outcome measure)
rectal sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806104 on ClinicalTrials.gov Archive Site
taxonomic composition of intestinal microbiota [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Fructo-oligosaccharides and Irritable Bowel Syndrome
Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Irritable Bowel Syndrome
  • Dietary Supplement: Fructo-oligosaccharides
    Dietary supplementation for 4 weeks
  • Dietary Supplement: Maltodextrins
    Dietary supplementation for 4 weeks
  • Experimental: 1
    Fructo-oligosaccharides
    Intervention: Dietary Supplement: Fructo-oligosaccharides
  • Placebo Comparator: 2
    Maltodextrins
    Intervention: Dietary Supplement: Maltodextrins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Spain
 
NCT00806104
FOS_QLV2
Not Provided
Frederique Respondek / Scientific Affairs Manager, Beghin Meiji
Beghin-Meiji
Not Provided
Principal Investigator: Michel Dapoigny, MD, PhD University Hospital, Clermont-Ferrand
Beghin-Meiji
January 2011

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