Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

Overview

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)

Full Title of Study: “Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2013

Interventions

  • 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

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Dicalcium phosphate, Maltodextrin and Magnesium stearate.
  • Experimental: Saccharomyces cerevisiae CNCM I-3856

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
    • Time Frame: baseline and week 8

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lesaffre International
  • Collaborator
    • BioFortis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David GENDRE, MD, Principal Investigator, BioFortis
    • Robin SPILLER, Professor of Gastroenterology, Principal Investigator, Nottingham Digestive Diseases Centre University Hospital

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