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

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Dietary advice following a low fermentation diet; Drug: Saccharomyces Boulardii 250 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04627337

CEIBO01

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice

Experimental group

Description:

Patients received 1 capsule of Saccharomyces boulardii 250 ug BID plus dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.

Treatment:

Behavioral: Dietary advice following a low fermentation diet

Drug: Saccharomyces Boulardii 250 MG

Dietary advice without medication

Active Comparator group

Description:

Patients received dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.

Treatment:

Behavioral: Dietary advice following a low fermentation diet