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NCT01613456 Clinical Trial

Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01613456
Other study ID # PEC11010
Secondary ID ID RCB: 2011-A00
Status Completed
Phase N/A
First received June 5, 2012
Last updated May 13, 2015
Start date December 2011
Est. completion date June 2013

Study information
Verified date May 2015
Source Lesaffre International
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 364
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Saccharomyces cerevisiae CNCM I-3856
2 capsules/day during 12 weeks
• Placebo
Capsule with comparable organoleptic properties and weight than the experimental product. 2 capsules/day during 12 weeks

Locations
Country Name City State
France Biofortis Saint Herblain

Sponsors (3)
Lead Sponsor Collaborator
Lesaffre International BioFortis, University of Nottingham

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week baseline and week 8 No
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