Clinical Trial

Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)

Study acronym: RESTORE
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated January 9, 2026 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to evaluate the effect of co-administering the probiotic Saccharomyces boulardii CNCM I-745 with amoxicillin-clavulanic acid on the intestinal and nasopharyngeal microbiota in children diagnosed with acute otitis media or acute bacterial sinusitis. The trial will also assess the potential of the probiotic to reduce antibiotic-associated diarrhea (AAD), antibiotic associated microbiota perturbation, and the spread of antibiotic resistance genes (ARGs).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-04.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-01-07
Trial Details
NCT Number NCT07015736
Lead Sponsor Eskisehir Osmangazi University
Conditions Antibiotic Associated Diarrhea, Acute Otitis Media, ACUTE SINUSITIS
Enrollment 100 participants
Start Date 2025-08-01
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-09