Efficacy of Probiotic Prophylaxis After The First Febrile Urinary Tract Infection in Children With Normal Urinary Tracts

Growing antibiotic resistance and debates over their efficacy for urinary tract infection (UTI) recurrence warrants studying nonantibiotic prophylaxis for preventing UTI recurrences. We randomly assigned 181 children, aged 4 months to 5 years, with a normal urinary tract after recovery from their first febrile UTI in a 1:1 ratio to receive a probiotic mixture of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, and Bifidobacterium lactis (n = 91) or placebo (n = 90) for a total of 18 months of therapy. The primary objective was to show the superiority of probiotic prophylaxis to placebo. The primary end point was composite cure (UTI-free survival) at 18 months, and the secondary end point was the median time to first UTI recurrence. The probiotics were superior to placebo with respect to the primary efficacy end point. At 18 months, composite cure was observed in 96.7% (3 of 91) of the patients in the probiotic group and 83.3% (15 of 90) of those in the placebo group (P = .02). The median time to the first incidence of UTI recurrence was 3.5 months (range, 1-4 months) and 6.5 months (range, 2-14 months) in the probiotic and placebo groups, respectively (P = .04). The main microorganism that caused recurrent UTI was Escherichia coli, followed by Klebsiella pneumoniae, and these results were not significantly different between the 2 groups. We found no specific adverse events among the participants who received the probiotic mixture during the course of therapy. The probiotics were more effective than placebo at reducing the risk of recurrent UTI in children with a normal urinary tract after their first episode of febrile UTI.