European Journal of Cardiovascular Medicine

Background: Antibiotic-associated diarrhea (AAD) represents a significant burden in pediatric healthcare, with probiotics posited as a potential mitigative strategy. This study aimed to evaluate the efficacy and safety of probiotic supplementation in reducing the incidence, severity, and duration of AAD among pediatric patients. Methods: In a double-blind, randomized, placebo-controlled trial, 214 pediatric patients receiving antibiotics were allocated to receive either probiotic supplementation or a placebo. The primary outcome was the incidence of AAD. Secondary outcomes included the severity and duration of diarrhea episodes, analyzed using appropriate statistical tests. Results: The probiotic group exhibited a significantly lower incidence of AAD (14% vs. 30%, p<0.01). Additionally, the severity (median severity score: 2 [IQR 1-3] vs. 3 [IQR 2-4], p=0.02) and duration (median duration: 2 days [IQR 1-3] vs. 4 days [IQR 3-5], p<0.01) of diarrhea were significantly reduced in the probiotic group compared to the placebo. Subgroup analysis indicated a pronounced benefit in children aged 1-5 years and those treated with penicillin. No significant difference in adverse events was observed between the groups. Conclusion: Probiotic supplementation is effective and safe in reducing the incidence, severity, and duration of AAD in pediatric patients, particularly among younger children and those on penicillin therapy. These findings support the adjunctive use of probiotics in pediatric antibiotic regimens