drugset / Trial / NCT05261152

S. Boulardii in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adults With Respiratory Tract Infections

NCT05261152 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Antibiotic-associated diarrhea (AAD) is the most common gastrointestinal complication of antibiotic use, with potentially serious clinical impact. The aim of this study is to assess the efficacy and safety of Saccharomyces boulardii in the prevention of AAD in adult patients with lower respiratory tract infection (LRTI) treated in a hospital. A multicenter, randomized, parallel-group, double-blind, placebo-controlled study is conducted whereby adults who are hospitalized due to LRTI and treated with intravenous antibiotics and randomized to capsules containing S. boulardii or indistinguishable placebo. The outcome measures were: relevant clinical features, gastrointestinal symptoms, and adverse events.

Timeline

Start
2017-11-01
Primary completion
2018-12-01
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject S. boulardii Other / unclassified 250 mg —