Irritable Bowel Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFructo-oligosaccharides
Dietary supplementation for 4 weeks
DIETARY_SUPPLEMENTMaltodextrins
Dietary supplementation for 4 weeks
Sponsors
Beghin-Meiji
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rectal sensitivity | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| taxonomic composition of intestinal microbiota | 4 weeks |
Countries
France, Spain
Outcome results
None listed