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

Eskisehir Osmangazi University

Status and phase: Active, not recruiting; Phase 4

Conditions: Acute Otitis Media; ACUTE SINUSITIS; Antibiotic Associated Diarrhea

Treatments: Dietary Supplement: Saccharomyces boulardii CNCM I-745; Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT07015736

Restore-V004-2025-6

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 <4 or >12 years

Chronic illness or GI disorders

History of antibiotic allergy or immunocompromise

Malnutrition or obesity

Recent gastrointestinal surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 4 patient groups

Probiotic 10 Days Group

Experimental group

Description:

Amoxicillin-clavulanic acid + S. boulardii for 10 days

Treatment:

Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension

Dietary Supplement: Saccharomyces boulardii CNCM I-745

Probiotic 21 Days Group

Experimental group

Description:

Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days)

Treatment:

Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension

Dietary Supplement: Saccharomyces boulardii CNCM I-745

Antibiotic-Only Group

Experimental group

Description:

Amoxicillin-clavulanic acid for 10 days (no probiotic)

Treatment:

Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension

Healthy Control Group

No Intervention group

Description:

No infection, antibiotics, or probiotics