NCT04627337

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

Efficacy and Safety of Saccharomyces Boulardii CNCM I-745 in the Treatment of Small Intestinal Bacterial Overgrowth in Patients Suffering From Irritable Bowel Syndrome With Diarrhea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Saccharomyces Boulardii 250 MG	Probiotic yeast in capsules
BEHAVIORAL	Dietary advice following a low fermentation diet	Medical advice was delivered to patients to follow a low fermentation diet. A list of food and beverages to avoid was delivered along with specified instructions provided by a health professional

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-07-30
• Completion: 2018-08-31
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: Argentina