Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613456
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : May 14, 2015
University of Nottingham
Information provided by (Responsible Party):
Lesaffre International

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)

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856 Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week [ Time Frame: baseline and week 8 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613456

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lesaffre International Identifier: NCT01613456     History of Changes
Other Study ID Numbers: PEC11010
ID RCB: 2011-A00915-36 ( Other Identifier: French Health Products Safety Agency )
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015

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