NCT07015736

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

Effect of Saccharomyces Boulardii CNCM I-745 on Antibiotic-perturbed Microbiota in Children: RESTORE STUDY

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Eskisehir Osmangazi University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

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).

Conditions

• Antibiotic Associated Diarrhea
• Acute Otitis Media
• ACUTE SINUSITIS

Interventions

Type	Name	Description
DRUG	Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension	Standard treatment (50-90 mg/kg/day for 10 days)
DIETARY_SUPPLEMENT	Saccharomyces boulardii CNCM I-745	Probiotic sachet, twice daily for 10 or 21 days depending on group assignment

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-03-01
• Completion: 2026-07-31
• First posted: 2025-06-11
• Last updated: 2026-01-09

Locations

4 sites across 1 country: Turkey (Türkiye)