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Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613456
First Posted: June 7, 2012
Last Update Posted: May 14, 2015
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.
Collaborators:
BioFortis
University of Nottingham
Information provided by (Responsible Party):
Lesaffre International
  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
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

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 8 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lesaffre International
ClinicalTrials.gov Identifier: NCT01613456     History of Changes
Other Study ID Numbers: PEC11010
ID RCB: 2011-A00915-36 ( Other Identifier: French Health Products Safety Agency )
First Submitted: June 5, 2012
First Posted: June 7, 2012
Last Update Posted: May 14, 2015
Last Verified: May 2015

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