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

June 5, 2012
May 22, 2014
December 2011
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01613456 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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)

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Irritable Bowel Syndrome
  • Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856
    2 capsules/day during 12 weeks
  • Dietary Supplement: Placebo

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

    2 capsules/day during 12 weeks

  • Placebo Comparator: Placebo
    Dicalcium phosphate, Maltodextrin and Magnesium stearate.
    Intervention: Dietary Supplement: Placebo
  • Experimental: Saccharomyces cerevisiae CNCM I-3856
    Intervention: Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
364
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01613456
PEC11010, ID RCB: 2011-A00915-36
Not Provided
Lesaffre International
Lesaffre International
  • BioFortis
  • University of Nottingham
Principal Investigator: David GENDRE, MD BioFortis
Principal Investigator: Robin SPILLER, Professor of Gastroenterology Nottingham Digestive Diseases Centre University Hospital
Lesaffre International
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP