Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborators:
BioFortis
University of Nottingham
Information provided by (Responsible Party):
Lesaffre International
ClinicalTrials.gov Identifier:
NCT01613456
First received: June 5, 2012
Last updated: May 22, 2014
Last verified: May 2014
  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:


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 ]

Enrollment: 364
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Biofortis
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: May 22, 2014
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:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014