A Randomized Controlled Trial of Probiotic Supplementation in Antibiotic Associated Diarrhea

Background Bacterial infections are said to be a cause of deaths in approximately 525,000 children annually as estimated by WHO. Antibiotic therapy, while essential for treating infections, can disrupt this delicate balance by reducing beneficial bacterial populations and allowing opportunistic pathogens to proliferate. The risk of antibiotic-associated diarrhea (AAD) is elevated by this dysbiosis. Therefore, the current study examines the effectiveness of probiotic therapy in young AAD patients. Methods This multicenter single blinded randomized controlled trial was conducted at Isra University Hospital Hyderabad from April 2021 to July 2024. A total of 208 participants with age between 6-12 years were recruited and randomly allocated into two groups; i.e. probiotics and placebo using computer based random sequence generation. AAD was the main outcome measure, and it was evaluated using a Bristol Stool Form Scale (BSFS) score of 5-7 per day in a 24-hour period. The data was analyzed on SPSS. Relative risk was assessed for the outcome. Results Antibiotic-associated diarrhea occurred in 13.6% of participants in the probiotic group and 17.1% in the placebo group, with a relative risk (RR) of 0.71 (95% CI: 0.39–1.22). Severe AAD was reported in 10.4% of the probiotic group and 11.3% of the placebo group (RR: 0.83, 95% CI: 0.51–1.69). Meanwhile, the incidence of mild AAD was similar between the groups, at 24.3% and 23.5%, respectively (RR: 1.01, 95% CI: 0.6–1.41). Conclusion The findings suggest that while probiotics may contribute to a modest reduction in the incidence and severity of antibiotic-associated diarrhea, their effect is not statistically significant.