Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

May 13, 2015 updated by: Lesaffre International

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Herblain, France, 44800
        • Biofortis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lesaffre International

Collaborators

University of Nottingham
BioFortis

Investigators

  • Principal Investigator: David Gendre, MD, Biofortis
  • Principal Investigator: Robin SPILLER, Professor of Gastroenterology, Nottingham Digestive Diseases Centre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEC11010
  • ID RCB: 2011-A00915-36 (Other Identifier: French Health Products Safety Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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