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Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Saccharomyces cerevisiae CNCM I-3856
Placebo
Sponsored by
Lesaffre International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Biofortis

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Saccharomyces cerevisiae CNCM I-3856

Arm Description

Dicalcium phosphate, Maltodextrin and Magnesium stearate.

Outcomes

Primary Outcome Measures

Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week

Secondary Outcome Measures

Full Information

First Posted
June 5, 2012
Last Updated
May 13, 2015
Sponsor
Lesaffre International
Collaborators
BioFortis, University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT01613456
Brief Title
Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome
Official Title
Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lesaffre International
Collaborators
BioFortis, University of Nottingham

4. Oversight

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dicalcium phosphate, Maltodextrin and Magnesium stearate.
Arm Title
Saccharomyces cerevisiae CNCM I-3856
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Saccharomyces cerevisiae CNCM I-3856
Intervention Description
2 capsules/day during 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Capsule with comparable organoleptic properties and weight than the experimental product. 2 capsules/day during 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
Time Frame
baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David GENDRE, MD
Organizational Affiliation
BioFortis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin SPILLER, Professor of Gastroenterology
Organizational Affiliation
Nottingham Digestive Diseases Centre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biofortis
City
Saint Herblain
ZIP/Postal Code
44800
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27403301
Citation
Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21. Erratum In: United European Gastroenterol J. 2017 Mar;5(2):304.
Results Reference
derived

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Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

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