Escherichia coli Nissle 1917 for the prevention of recurrent uncomplicated urinary tract infections in women: a pilot randomized placebo-controlled trial
Abstract
BACKGROUND
Recurrent urinary tract infections (rUTIs) represent a common clinical condition in women and are frequently associated with repeated antibiotic exposure. Increasing interest has therefore focused on non-antimicrobial preventive strategies. Escherichia coli Nissle 1917 (EcN) is a probiotic strain with documented antagonistic activity against uropathogens, although clinical evidence supporting its use in adult women with rUTIs remains limited.
OBJECTIVE
To evaluate the efficacy and safety of EcN compared with placebo in women with recurrent uncomplicated urinary tract infections. Materials and methods: This pilot multicentre double-blind randomized placebo-controlled trial enrolled 50 women with recurrent uncomplicated UTIs. Patients were randomized to receive EcN or placebo and followed for 26 weeks. The primary endpoint was the occurrence of at least one microbiological recurrence during follow-up. Secondary endpoints included number of recurrences, time to first recurrence, urine culture results at scheduled follow-up visits, and patient-reported outcomes assessed using SF-36, PPBC, and PGI-I questionnaires.
RESULTS
Fifty patients were included in the analysis (EcN n = 24; placebo n = 26). At least one microbiological recurrence during follow-up occurred in 4/24 patients (16.7%) treated with EcN compared with 11/26 patients (42.3%) receiving placebo, corresponding to a relative risk (RR) of 0.39 (95% CI 0.14-1.14; p = 0.089). Positive urine cultures at 12 weeks…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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