Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

Lesaffre

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01613456

PEC11010

ID RCB: 2011-A00915-36 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 364 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Dicalcium phosphate, Maltodextrin and Magnesium stearate.

Treatment:

Dietary Supplement: Placebo

Saccharomyces cerevisiae CNCM I-3856

Experimental group

Treatment:

Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856