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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Saccharomyces Boulardii CNCM I-745 on Antibiotic-perturbed Microbiota in Children: RESTORE STUDY
- ClinicalTrials.gov ID
- NCT07015736
- Acronym / sponsor ID
- RESTORE / Restore-V004-2025-6
- Keywords
- antibiotic associated diarrhea, probiotic, microbiota, microbiome, Saccharomyces boulardii
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Probiotic 10 Days Group | Experimental | Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension, Dietary Supplement: Saccharomyces boulardii CNCM I-745Amoxicillin-clavulanic acid + S. boulardii for 10 days |
| Probiotic 21 Days Group | Experimental | Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension, Dietary Supplement: Saccharomyces boulardii CNCM I-745Amoxicillin-clavulanic acid for 10 days + S. boulardii for 21 days (overlapping first 10 days) |
| Antibiotic-Only Group | Experimental | Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionAmoxicillin-clavulanic acid for 10 days (no probiotic) |
| Healthy Control Group | No intervention | –No infection, antibiotics, or probiotics |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed with acute otitis medica or acute rhinosinusitis
- No chronic diseases or recent antibiotic/probiotic use (past 8 weeks)
- Parental consent obtained
Key exclusion criteria (5 listed)
- Age <4 or >12 years
- Chronic illness or GI disorders
- History of antibiotic allergy or immunocompromise
- Malnutrition or obesity
- Recent gastrointestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionStandard treatment (50-90 mg/kg/day for 10 days) | Drug | Antibiotic-Only Group, Probiotic 10 Days Group, Probiotic 21 Days Group |
| Saccharomyces boulardii CNCM I-745Probiotic sachet, twice daily for 10 or 21 days depending on group assignment | Dietary supplement | Probiotic 10 Days Group, Probiotic 21 Days Group |
Primary outcome
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)
3 secondary outcomes
Change in intestinal microbiota virome composition
Time frame: 0, 10, 14, 56 days of study
Change in intestinal microbiota mycobiome composition
Time frame: 0, 10, 14, 21 days of study
Changes in nasopharyngeal microbiota composition
Time frame: 0, 10, 21, 56 days of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intestinal microbiota bacteria composition (time frame: 0, 10, 21 and 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.