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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic 10 Days Group | Experimental | Amoxicillin-clavulanic acid + S. boulardii for 10 days |
|
| Probiotic 21 Days Group | Experimental | Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days) |
|
| Antibiotic-Only Group | Experimental | Amoxicillin-clavulanic acid for 10 days (no probiotic) |
|
| Healthy Control Group | No Intervention | No infection, antibiotics, or probiotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension | Drug | Standard treatment (50-90 mg/kg/day for 10 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in intestinal microbiota bacteria composition | Change in intestinal microbiota bacteria composition with WGS | 0, 10, 21 and 56 days |
| Potential changes in antibiotic resistant genes (ARGs) | Potential changes in antibiotic resistant genes (ARGs) | 0, 10, 21, and 56 days of study |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intestinal microbiota virome composition | Change in intestinal microbiota virome composition | 0, 10, 14, 56 days of study |
| Change in intestinal microbiota mycobiome composition | Change in intestinal microbiota mycobiome composition |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskisehir Osmangazi University | Eskişehir | 26040 | Turkey (Türkiye) | |||
| Acibadem Univsersity Faculty of Medicine |
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Microbiota analysis will be blinded
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| Saccharomyces boulardii CNCM I-745 | Dietary Supplement | Probiotic sachet, twice daily for 10 or 21 days depending on group assignment |
|
| 0, 10, 14, 21 days of study |
| Changes in nasopharyngeal microbiota composition | Changes in nasopharyngeal microbiota bacteriaal composition | 0, 10, 21, 56 days of intervention |
| Istanbul |
| Turkey (Türkiye) |
| Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital | Istanbul | Turkey (Türkiye) |
| Şişli Hamidiye Etfal Training and Research Hospital | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
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