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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Antibiotic Associated Diarrhea Acute Otitis Media ACUTE SINUSITIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Microbiota analysis will be blinded

Study Groups

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Probiotic 10 Days Group

Amoxicillin-clavulanic acid + S. boulardii for 10 days

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Saccharomyces boulardii CNCM I-745

Intervention Type DIETARY_SUPPLEMENT

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

Probiotic 21 Days Group

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Saccharomyces boulardii CNCM I-745

Intervention Type DIETARY_SUPPLEMENT

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

Antibiotic-Only Group

Amoxicillin-clavulanic acid for 10 days (no probiotic)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Healthy Control Group

No infection, antibiotics, or probiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type DRUG

Saccharomyces boulardii CNCM I-745

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes