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CompletedNCT01613456Updated May 14, 2015

Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

An interventional study of Saccharomyces cerevisiae CNCM I-3856 and Placebo in Irritable Bowel Syndrome, sponsored by Lesaffre International. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-14.

Sponsored by Lesaffre International · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
364
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 364 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Lesaffre International is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
364 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Dicalcium phosphate, Maltodextrin and Magnesium stearate.

    Dietary Supplement: Placebo

  • Experimental
    Saccharomyces cerevisiae CNCM I-3856

    Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856

Interventions

  • Dietary supplementSaccharomyces cerevisiae CNCM I-3856

    2 capsules/day during 12 weeks

  • Dietary supplementPlacebo

    Capsule with comparable organoleptic properties and weight than the experimental product. 2 capsules/day during 12 weeks

06

What researchers measure

Primary outcomes

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

    Time frame: baseline and week 8

07

Study locations

1 site
  • Biofortis
    Saint Herblain, 44800, France
08

References and documents

Publications

  • 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. doi: 10.1177/2050640616641615. PubMed 27403301 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01613456
Lead sponsor
Lesaffre International
Collaborators
BioFortis, University of Nottingham
Responsible party
Sponsor
First posted
Jun 7, 2012
Start date
Dec 2011
Primary completion
Jun 2013
Completion
Jun 2013
Last update
May 14, 2015

Study contacts

David GENDRE, MD
principal investigator · BioFortis
Robin SPILLER, Professor of Gastroenterology
principal investigator · Nottingham Digestive Diseases Centre University Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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