Antibiotic Associated DiarrheaPhase 4RESTORENCT07015736
Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)
A Phase 4 study testing Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension and Saccharomyces boulardii CNCM I-745 in people with Antibiotic Associated Diarrhea and Acute Otitis Media, run by Eskisehir Osmangazi University at 4 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Associated Diarrhea, Acute Otitis Media, ACUTE SINUSITIS
- What is being tested?
- Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension and Saccharomyces boulardii CNCM I-745
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 10 Sep 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosed with acute otitis medica or acute rhinosinusitis
- No chronic diseases or recent antibiotic/probiotic use (past 8 weeks)
- Parental consent obtained
Who cannot join
- Age <4 or >12 years
- Chronic illness or GI disorders
- History of antibiotic allergy or immunocompromise
- Malnutrition or obesity
- Recent gastrointestinal surgery
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Eskisehir Osmangazi University
Eskişehir, 26040
Acibadem Univsersity Faculty of Medicine
Istanbul
Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital
Istanbul
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: Effect of Saccharomyces Boulardii CNCM I-745 on Antibiotic-perturbed Microbiota in Children: 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).
- Being tested
- Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension, Saccharomyces boulardii CNCM I-745
- Keywords
- antibiotic associated diarrhea, probiotic, microbiota, microbiome, Saccharomyces boulardii
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionDrug
Standard treatment (50-90 mg/kg/day for 10 days)
Saccharomyces boulardii CNCM I-745Dietary supplement
Probiotic sachet, twice daily for 10 or 21 days depending on group assignment
| Study group | Role | What they receive |
|---|---|---|
| Probiotic 10 Days Group | Experimental | Amoxicillin-clavulanic acid + S. boulardii for 10 days Receives: Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension; Dietary Supplement: Saccharomyces boulardii CNCM I-745 |
| Probiotic 21 Days Group | Experimental | Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days) Receives: Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension; Dietary Supplement: Saccharomyces boulardii CNCM I-745 |
| Antibiotic-Only Group | Experimental | Amoxicillin-clavulanic acid for 10 days (no probiotic) Receives: Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension |
| Healthy Control Group | No intervention | No infection, antibiotics, or probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal microbiota bacteria composition
Change in intestinal microbiota bacteria composition with WGS
Measured: 0, 10, 21 and 56 days
Potential changes in antibiotic resistant genes (ARGs)
Potential changes in antibiotic resistant genes (ARGs)
Measured: 0, 10, 21, and 56 days of study
Secondary outcomes (3)
Change in intestinal microbiota virome composition
Change in intestinal microbiota virome composition
Measured: 0, 10, 14, 56 days of study
Change in intestinal microbiota mycobiome composition
Change in intestinal microbiota mycobiome composition
Measured: 0, 10, 14, 21 days of study
Changes in nasopharyngeal microbiota composition
Changes in nasopharyngeal microbiota bacteriaal composition
Measured: 0, 10, 21, 56 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Aug 2025
- Primary completion1 Mar 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ener Cagri DINLEYICI, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015736
- Sponsor's protocol ID
- Restore-V004-2025-6
- Acronym
- RESTORE
- Status last verified
- Jan 2026
- First submitted
- 4 Jun 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No