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NCT Number: NCT07015736

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Antibiotic Associated Diarrhea Acute Otitis Media Acute Sinusitis Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eskisehir Osmangazi University, Eskişehir, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Standard treatment (50-90 mg/kg/day for 10 days)

Saccharomyces boulardii CNCM I-745

Dietary Supplement

Probiotic sachet, twice daily for 10 or 21 days depending on group assignment

Primary outcomes

  1. Change in intestinal microbiota bacteria composition

    Time frame: 0, 10, 21 and 56 days

    Change in intestinal microbiota bacteria composition with WGS

  2. Potential changes in antibiotic resistant genes (ARGs)

    Time frame: 0, 10, 21, and 56 days of study

    Potential changes in antibiotic resistant genes (ARGs)

Secondary outcomes

  1. Change in intestinal microbiota virome composition

    Time frame: 0, 10, 14, 56 days of study

    Change in intestinal microbiota virome composition

  2. Change in intestinal microbiota mycobiome composition

    Time frame: 0, 10, 14, 21 days of study

    Change in intestinal microbiota mycobiome composition

  3. Changes in nasopharyngeal microbiota composition

    Time frame: 0, 10, 21, 56 days of intervention

    Changes in nasopharyngeal microbiota bacteriaal composition

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Acronym: RESTORE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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