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Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)
Sponsor: Eskisehir Osmangazi University
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).
Official title: Effect of Saccharomyces Boulardii CNCM I-745 on Antibiotic-perturbed Microbiota in Children: RESTORE STUDY
Key Details
Gender
All
Age Range
4 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-08-01
Completion Date
2026-07-31
Last Updated
2026-01-09
Healthy Volunteers
Yes
Interventions
Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension
Standard treatment (50-90 mg/kg/day for 10 days)
Saccharomyces boulardii CNCM I-745
Probiotic sachet, twice daily for 10 or 21 days depending on group assignment
Locations (4)
Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye)
Acibadem Univsersity Faculty of Medicine
Istanbul, Turkey (Türkiye)
Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, Turkey (Türkiye)