Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome
Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study
2 other identifiers
interventional
364
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMay 14, 2015
May 1, 2015
1.5 years
June 5, 2012
May 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
baseline and week 8
Study Arms (2)
Placebo
PLACEBO COMPARATORDicalcium phosphate, Maltodextrin and Magnesium stearate.
Saccharomyces cerevisiae CNCM I-3856
EXPERIMENTALInterventions
2 capsules/day during 12 weeks
Capsule with comparable organoleptic properties and weight than the experimental product. 2 capsules/day during 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lesaffre Internationallead
- BioFortiscollaborator
- University of Nottinghamcollaborator
Study Sites (1)
Biofortis
Saint-Herblain, 44800, France
Related Publications (1)
Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21.
PMID: 27403301DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David GENDRE, MD
BioFortis
- PRINCIPAL INVESTIGATOR
Robin SPILLER, Professor of Gastroenterology
Nottingham Digestive Diseases Centre University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 7, 2012
Study Start
December 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
May 14, 2015
Record last verified: 2015-05