Active — Not RecruitingPhase 4

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

Turkey (Türkiye)100 participantsStarted 2025-08-01

Plain-language 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).

Who can participate

Age range4 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in intestinal microbiota bacteria composition

Timeframe: 0, 10, 21 and 56 days

Potential changes in antibiotic resistant genes (ARGs)

Timeframe: 0, 10, 21, and 56 days of study

Trial details

NCT IDNCT07015736

SponsorEskisehir Osmangazi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Antibiotic Associated Diarrhea trials