Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Dicalcium phosphate, Maltodextrin and Magnesium stearate.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

2 capsules/day during 12 weeks

Saccharomyces cerevisiae CNCM I-3856

Group Type EXPERIMENTAL

Saccharomyces cerevisiae CNCM I-3856

Intervention Type DIETARY_SUPPLEMENT

2 capsules/day during 12 weeks

Interventions

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Saccharomyces cerevisiae CNCM I-3856

2 capsules/day during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

2 capsules/day during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No