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

NCT07015736 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-03-01
Completion
2026-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015736 on ClinicalTrials.gov