Effect of Saccharomyces Boulardii CNCM I-745 on Antibiotic-perturbed Microbiota in Children: RESTORE STUDY
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Change in intestinal microbiota bacteria composition
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Microbiota analysis will be blinded
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Antibiotic-Only Group
Amoxicillin-clavulanic acid for 10 days (no probiotic)
Intervention: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension (Drug)
Probiotic 10 Days Group
Amoxicillin-clavulanic acid + S. boulardii for 10 days
Intervention: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension (Drug)
Probiotic 10 Days Group
Amoxicillin-clavulanic acid + S. boulardii for 10 days
Intervention: Saccharomyces boulardii CNCM I-745 (Dietary Supplement)
Healthy Control Group
No infection, antibiotics, or probiotics
Probiotic 21 Days Group
Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days)
Intervention: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension (Drug)
Probiotic 21 Days Group
Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days)
Intervention: Saccharomyces boulardii CNCM I-745 (Dietary Supplement)
Outcomes
Primary Outcomes
Change in intestinal microbiota bacteria composition
Time Frame: 0, 10, 21 and 56 days
Change in intestinal microbiota bacteria composition with WGS
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
- Change in intestinal microbiota virome composition(0, 10, 14, 56 days of study)
- Change in intestinal microbiota mycobiome composition(0, 10, 14, 21 days of study)
- Changes in nasopharyngeal microbiota composition(0, 10, 21, 56 days of intervention)
Investigators
Ener Cagri DINLEYICI
Professor in Pediatrics
Eskisehir Osmangazi University