Fructo-oligosaccharides and Irritable Bowel Syndrome

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. Identifier: NCT00806104
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : January 17, 2011
Information provided by:

December 9, 2008
December 10, 2008
January 17, 2011
March 2009
July 2010   (Final data collection date for primary outcome measure)
rectal sensitivity [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00806104 on Archive Site
taxonomic composition of intestinal microbiota [ Time Frame: 4 weeks ]
Same as current
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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
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Irritable Bowel Syndrome
  • Dietary Supplement: Fructo-oligosaccharides
    Dietary supplementation for 4 weeks
  • Dietary Supplement: Maltodextrins
    Dietary supplementation for 4 weeks
  • Experimental: 1
    Intervention: Dietary Supplement: Fructo-oligosaccharides
  • Placebo Comparator: 2
    Intervention: Dietary Supplement: Maltodextrins
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
France,   Spain
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Frederique Respondek / Scientific Affairs Manager, Beghin Meiji
Not Provided
Principal Investigator: Michel Dapoigny, MD, PhD University Hospital, Clermont-Ferrand
January 2011

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