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Completed

NCT Number: NCT01613456

Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

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)

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis

Saint-Herblain, 44800, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saccharomyces cerevisiae CNCM I-3856

Dietary Supplement

2 capsules/day during 12 weeks

Placebo

Dietary Supplement

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

2 capsules/day during 12 weeks

Primary outcomes

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

    Time frame: baseline and week 8

Sponsors and collaborators

Lead sponsor

Lesaffre International

Industry

Collaborators

  • BioFortis
  • University of Nottingham

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2012
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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