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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Standard treatment (50-90 mg/kg/day for 10 days)
Probiotic sachet, twice daily for 10 or 21 days depending on group assignment
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)
Change in intestinal microbiota bacteria composition
Change in intestinal microbiota bacteria composition with WGS
Time frame: 0, 10, 21 and 56 days
Potential changes in antibiotic resistant genes (ARGs)
Potential changes in antibiotic resistant genes (ARGs)
Time frame: 0, 10, 21, and 56 days of study
Change in intestinal microbiota virome composition
Change in intestinal microbiota virome composition
Time frame: 0, 10, 14, 56 days of study
Change in intestinal microbiota mycobiome composition
Change in intestinal microbiota mycobiome composition
Time frame: 0, 10, 14, 21 days of study
Changes in nasopharyngeal microbiota composition
Changes in nasopharyngeal microbiota bacteriaal composition
Time frame: 0, 10, 21, 56 days of intervention
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