CompletedPhase 4

Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth

Argentina71 participantsStarted 2017-02-01

Plain-language summary

Non-constipated irritable bowel syndrome is a common disorder that may be related to small intestinal bacterial overgrowth. Saccharomyces boulardii CNCM I-745 is a probiotic yeast that has proven efficacy for the treatment of acute gastroenteritis and antibiotic-associated diarrhea. However, its efficacy for the treatment of diarrhea-predominant irritable bowel syndrome with small intestinal bacterial overgrowth has not been assessed. Hence, an exploratory randomized, open label trial comparing the efficacy and safety of Saccharomyes boulardii CNCM I-745 plus diet administration versus diet administration only for 15 days among adult patients with the aforementioned condition was conducted.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients * Diagnosis of Irritable Bowel syndrome according to Rome III criteria * Diagnosis of concomitant small intestinal bacterial overgorwth (SIBO) by breath test Exclusion Criteria: * Pregnancy * Diagnosis of Celiac disease * Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions * Immunosuppression * Diagnosis of active cancer

What they're measuring

Change in symptom severity measured by the Irritable Bowel Syndrome Symptom Severity Scale

Timeframe: 15 days

Trial details

NCT IDNCT04627337

SponsorCentro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-30

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials