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

Phase 4

Not yet recruiting

• Conditions: Antibiotic Associated Diarrhea; Acute Otitis Media; ACUTE SINUSITIS
• Interventions: Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension; Dietary Supplement: Saccharomyces boulardii CNCM I-745

• Registration Number: NCT07015736
• Lead Sponsor: Eskisehir Osmangazi University

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study Start: 2025-06-10
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Age <4 or >12 years

Chronic illness or GI disorders

History of antibiotic allergy or immunocompromise

Malnutrition or obesity

Recent gastrointestinal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic 10 Days Group	Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension	Amoxicillin-clavulanic acid + S. boulardii for 10 days
Probiotic 10 Days Group	Saccharomyces boulardii CNCM I-745	Amoxicillin-clavulanic acid + S. boulardii for 10 days
Probiotic 21 Days Group	Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension	Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days)
Probiotic 21 Days Group	Saccharomyces boulardii CNCM I-745	Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days)
Antibiotic-Only Group	Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension	Amoxicillin-clavulanic acid for 10 days (no probiotic)

Primary Outcome Measures

Name	Time	Method
Change in intestinal microbiota bacteria composition	0, 10, 21 and 56 days	Change in intestinal microbiota bacteria composition with WGS
Potential changes in antibiotic resistant genes (ARGs)	0, 10, 21, and 56 days of study	Potential changes in antibiotic resistant genes (ARGs)

Secondary Outcome Measures

Name	Time	Method
Change in intestinal microbiota virome composition	0, 10, 14, 56 days of study	Change in intestinal microbiota virome composition
Change in intestinal microbiota mycobiome composition	0, 10, 14, 21 days of study	Change in intestinal microbiota mycobiome composition
Changes in nasopharyngeal microbiota composition	0, 10, 21, 56 days of intervention	Changes in nasopharyngeal microbiota bacteriaal composition

Trial Locations

Locations (1)

Eskisehir Osmangazi University; 🇹🇷 Eskisehir, Turkey