NCT07015736

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
3mo left

Started Aug 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Aug 2025Jul 2026

First Submitted

Initial submission to the registry

June 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

June 4, 2025

Last Update Submit

January 7, 2026

Conditions

Acute Otitis MediaAntibiotic Associated DiarrheaACUTE SINUSITIS

Keywords

antibiotic associated diarrheaprobioticmicrobiotamicrobiomeSaccharomyces boulardii

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (4)

Probiotic 10 Days Group

EXPERIMENTAL

Amoxicillin-clavulanic acid + S. boulardii for 10 days

Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionDietary 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)

Drug: Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspensionDietary Supplement: Saccharomyces boulardii CNCM I-745

Antibiotic-Only Group

EXPERIMENTAL

Amoxicillin-clavulanic acid for 10 days (no probiotic)

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

Healthy Control Group

NO INTERVENTION

No infection, antibiotics, or probiotics

Interventions

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

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

Antibiotic-Only GroupProbiotic 10 Days GroupProbiotic 21 Days Group
Saccharomyces boulardii CNCM I-745DIETARY_SUPPLEMENT

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

Probiotic 10 Days GroupProbiotic 21 Days Group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with acute otitis medica or acute rhinosinusitis
  • No chronic diseases or recent antibiotic/probiotic use (past 8 weeks)
  • Parental consent obtained

You may not qualify if:

  • Age \<4 or \>12 years
  • Chronic illness or GI disorders
  • History of antibiotic allergy or immunocompromise
  • Malnutrition or obesity
  • Recent gastrointestinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Eskisehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

Acibadem Univsersity Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Amoxicillin-Potassium Clavulanate CombinationSuspensions

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsColloidsComplex MixturesDosage Forms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Microbiota analysis will be blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Pediatrics

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 11, 2025

Study Start

August 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(4)