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Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

This study is currently recruiting participants.
Verified January 2012 by Lesaffre International
Sponsor:
Collaborators:
BioFortis
University of Nottingham
Information provided by (Responsible Party):
Lesaffre International
ClinicalTrials.gov Identifier:
NCT01613456
First received: June 5, 2012
Last updated: June 6, 2012
Last verified: January 2012
History of Changes
  Purpose

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)


Condition Intervention
Irritable Bowel Syndrome
 Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lesaffre International:

Primary Outcome Measures:
  • Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 364
Study Start Date: December 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Dicalcium phosphate, Maltodextrin and Magnesium stearate.
 Dietary Supplement: Placebo

Capsule with comparable organoleptic properties and weight than the experimental product.

2 capsules/day during 12 weeks
Experimental: Saccharomyces cerevisiae CNCM I-3856 Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856
2 capsules/day during 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613456

Contacts
Contact: Séverine DUBREUIL, Monitor (0)2 40 20 57 99 ext + 33

Locations
France
Biofortis Recruiting
Saint Herblain, France, 44800
Sponsors and Collaborators
Lesaffre International
BioFortis
University of Nottingham
Investigators
Principal Investigator: David GENDRE, MD BioFortis
Principal Investigator: Robin SPILLER, Professor of Gastroenterology Nottingham Digestive Diseases Centre University Hospital
  More Information

No publications provided

Responsible Party: Lesaffre International
ClinicalTrials.gov Identifier: NCT01613456     History of Changes
Other Study ID Numbers: PEC11010, ID RCB: 2011-A00915-36
Study First Received: June 5, 2012
Last Updated: June 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Irritable Bowel Syndrome
 Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013