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Fructo-oligosaccharides and Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT00806104
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : January 17, 2011
Sponsor:
Information provided by:
Beghin-Meiji

Brief Summary:
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 or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Fructo-oligosaccharides Dietary Supplement: Maltodextrins Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. rectal sensitivity [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. taxonomic composition of intestinal microbiota [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Frederique Respondek / Scientific Affairs Manager, Beghin Meiji
ClinicalTrials.gov Identifier: NCT00806104     History of Changes
Other Study ID Numbers: FOS_QLV2
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: January 17, 2011
Last Verified: January 2011

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