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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07015736

Acronym

RESTORE

Enrollment

100

Registered

2025-06-11

Start date

2025-08-01

Completion date

2026-09-10

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Otitis Media, ACUTE SINUSITIS, Antibiotic Associated Diarrhea

Keywords

antibiotic associated diarrhea, probiotic, microbiota, microbiome, Saccharomyces boulardii

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).

Interventions

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

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

DIETARY_SUPPLEMENTSaccharomyces boulardii CNCM I-745

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Masking description

Microbiota analysis will be blinded

Eligibility

Sex/Gender

ALL

Age

4 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026