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NCT00806104 Clinical Trial

Fructo-oligosaccharides and Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00806104
Other study ID # FOS_QLV2
Secondary ID
Status Completed
Phase N/A
First received December 9, 2008
Last updated January 14, 2011
Start date March 2009
Est. completion date December 2010

Study information
Verified date January 2011
Source Beghin-Meiji
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Fructo-oligosaccharides
Dietary supplementation for 4 weeks
• Maltodextrins
Dietary supplementation for 4 weeks

Locations
Country Name City State
France CHU Clermont Ferrand Clermont-Ferrand
Spain Vall Hebron Hospital Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Beghin-Meiji

Countries where clinical trial is conducted

France,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary rectal sensitivity 4 weeks No
Secondary taxonomic composition of intestinal microbiota 4 weeks No
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