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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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07015736). StuddyBuddy aggregates publicly available trial information.