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Completed
NCT07015736
Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)
Conditions: Antibiotic Associated Diarrhea, Acute Otitis Media, ACUTE SINUSITIS
Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 100
Sponsor: Eskisehir Osmangazi University
Location: Eskisehir Osmangazi University Eskişehir
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).
Eligibility Criteria
Inclusion Criteria
Diagnosed with acute otitis medica or acute rhinosinusitis
No chronic diseases or recent antibiotic/probiotic use (past 8 weeks)
Parental consent obtained
Exclusion Criteria:
Age \12 years
Chronic illness or GI disorders
History of antibiotic allergy or immunocompromise
Malnutrition or obesity
Recent gastrointestinal surgery
Source: ClinicalTrials.gov (NCT07015736). StuddyBuddy aggregates publicly available trial information.