Irritable Bowel Syndrome
Conditions
Brief summary
The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)
Interventions
DIETARY_SUPPLEMENTSaccharomyces cerevisiae CNCM I-3856
2 capsules/day during 12 weeks
DIETARY_SUPPLEMENTPlacebo
Capsule with comparable organoleptic properties and weight than the experimental product. 2 capsules/day during 12 weeks
Sponsors
BioFortis
University of Nottingham
Lesaffre International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded * IBS-C with less than 3 complete spontaneous bowel movements/week * IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score * Subject able of and willing to comply with the protocol and to give their written informed consents
Exclusion criteria
* History of chronic gastrointestinal disorders * History of lactose intolerance * History of gluten intolerance * Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics) * Eating disorders * Pregnancy in progress
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week | baseline and week 8 |
Countries
France
Outcome results
None listed