Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)

Launched by ESKISEHIR OSMANGAZI UNIVERSITY · Jun 4, 2025

Keywords

ClinConnect Summary

The RESTORE Study is a clinical trial that looks at how a probiotic called Saccharomyces boulardii CNCM I-745 may help children who are taking antibiotics for infections like ear infections (acute otitis media) and sinus infections (acute bacterial sinusitis). The researchers want to see if giving this probiotic along with the antibiotic amoxicillin-clavulanic acid can improve gut health, reduce the risk of diarrhea caused by antibiotics, and help prevent changes in the body's natural bacteria and the spread of antibiotic resistance.

To be part of this study, children must be between 4 and 12 years old and diagnosed with one of the targeted infections. They should not have any chronic health issues or have taken antibiotics or probiotics in the last 8 weeks. Parents will need to give their consent for their child to participate. While the study is not yet recruiting participants, it will provide valuable insights into how probiotics can impact the health of children undergoing antibiotic treatment.

Gender

ALL

Eligibility criteria

• • 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