drugset / Trial / NCT05261152
S. Boulardii in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adults With Respiratory Tract Infections
Phase 4
Completed
96 enrolled
Clinical Centre of Serbia
Institute for Pulmonary Diseases of Vojvodina · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S. boulardii | Other / unclassified | 250 mg | — |