A Randomized Controlled Trial of Probiotic Supplementation in Antibiotic-Associated Diarrhea

Probiotic in Antibiotic-Associated Diarrhea

Abstract

Background: Bacterial infections account for approximately 525,000 deaths annually among children worldwide, as estimated by the World Health Organization (WHO). Although antibiotics are essential for the treatment of bacterial infections, their use can disrupt the normal gut microbiota by reducing beneficial bacteria and promoting the growth of opportunistic pathogens. This imbalance increases the risk of antibiotic-associated diarrhea (AAD). Objective: To evaluate the effectiveness of probiotic therapy in reducing the incidence and severity of antibiotic-associated diarrhea in pediatric patients. Study Design: Multicenter, single-blinded randomized controlled trial. Settings: Isra Hospital, Hyderabad Pakistan. Duration: April 2021 to July 2024. Methods: A total of 208 children aged 6–12 years receiving antibiotic therapy were enrolled and randomly allocated into probiotic and placebo groups using computer-generated randomization. The primary outcome was the occurrence of antibiotic-associated diarrhea, assessed using the Bristol Stool Form Scale (BSFS), defined as a score of 5–7 stools per day over a 24-hour period. Data were analyzed using SPSS software. Results: Antibiotic-associated diarrhea was observed in 13.6% of participants in the probiotic group and 17.1% in the placebo group, yielding a relative risk (RR) of 0.71 (95% CI: 0.39–1.22). Severe AAD occurred in 10.4% of the probiotic group compared to 11.3% of the placebo group (RR: 0.83; 95% CI: 0.51–1.69). The incidence of mild AAD was comparable between the probiotic and placebo groups (24.3% vs. 23.5%, respectively; RR: 1.01; 95% CI: 0.60–1.41). Conclusion: Probiotic supplementation may lead to a modest reduction in the incidence and severity of antibiotic-associated diarrhea in children; however, the observed differences were not statistically significant.