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Not Yet Recruiting 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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07785206). StuddyBuddy aggregates publicly available trial information.