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NCT07785206
Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea
Conditions: Antibiotic Associated Diarrhea, Upper Respiratory Tract Infection
Sex: All
Ages: 6 Months – 5 Years
Healthy volunteers: No
Phase: NA
Enrollment: 88
Sponsor: University of Child Health Sciences and Children's Hospital, Lahore
Location: University of Child Health sciences, Children's hospital,Lahore Lahore Punjab Province
Summary
Antibiotic-associated diarrhea (AAD) is a common adverse effect in pediatric patients receiving broad-spectrum antibiotics such as co-amoxiclav for upper respiratory tract infections (URTI). This study aims to evaluate the effectiveness of the probiotic Saccharomyces boulardii in preventing antibiotic-associated diarrhea among children aged 6 months to 5 years receiving co-amoxiclav. Participants will be randomly allocated to receive either standard co-amoxiclav therapy alone or co-amoxiclav combined with Saccharomyces boulardii for 5 days. The primary objective is to evaluate whether the addition of Saccharomyces boulardii reduces the incidence of diarrhea during and up to 14 days following antibiotic therapy.
Eligibility Criteria
Inclusion Criteria:
* Children aged 6 months to 5 years presenting with upper respiratory tract infection (URTI)
* Prescribed standard oral co-amoxiclav therapy
* Both male and female patients
* Written informed consent provided by parents or legal guardians
Exclusion Criteria:
* Presence of diarrhea at the time of study enrollment
* Prior use of probiotics during the current course of illness
* Receipt of any antibiotic other than co-amoxiclav within the 72 hours preceding enrollment
* Concomitant use of other medications
* Known allergy to co-amoxiclav or the probiotic Saccharomyces boulardii
* Confirmed immunodeficiency disorder or current receipt of immunosuppressive therapy
* History of chronic diarrhea
* Presence of 3rd degree (severe) malnutrition
* Presence of systemic symptoms or infections other than URTI (e.g., lower respiratory tract infection, jaundice)
Source: ClinicalTrials.gov (NCT07785206). StuddyBuddy aggregates publicly available trial information.