Escherichia coli Nissle 1917 as adjuvant therapy in patients with chronic bacterial prostatitis: a non-blinded, randomized, controlled trial.

To evaluate the efficacy and safety of Escherichia coli Nissle 1917 (EcN) in association with levofloxacin in patients with chronic bacterial prostatitis (CBP).

Patients with CBP referred to our clinic from September 2017 to July 2019 were enrolled. At baseline, the symptomatology was assessed with the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI), while the Meares-Stamey test was used to diagnose the infection. Patients were randomized (1:1) in two groups (A and B). All subjects underwent oral administration of Levoxacin® 500 mg once daily for 4 weeks. Only the patients in Group B underwent oral administration of EcN® 320 mg, twice daily for 4 weeks and then once daily for 8 weeks. After 3 months, each patient repeated the NIH-CPSI questionnaire, while the Meares-Stamey test was repeated at 3 and 6 months in patients who reported persistent symptoms. All adverse events (AEs) were recorded.

A total of 110 patients were enrolled. After 3 months patients in Group B reported a significantly lower NIH-CPSI score (5.85 ± 3.07 vs. 7.64 ± 3.86; p = 0.009) and biological recurrences rate (9.8 vs. 26.9%; p = 0.043). At 6 months the biological recurrences rate was significantly lower in Group B (8.7 vs. 28.9%; p = 0.038). Only three patients in Group A and six in Group B (p = 0.25) complained mild AEs.

Combination therapy with EcN and levofloxacin allows a better control of symptoms and biological recurrences in patients with CBP, without worsening the safety of the treatment.

World journal of urology. 2021 Jul 02 [Epub ahead of print]

Celeste Manfredi, Francesco P Calace, Ferdinando Fusco, Carmelo Quattrone, Dario Giordano, Felice Crocetto, Massimiliano Creta, Marco De Sio, Davide Arcaniolo

Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy., Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. ., Department of Urology, University "Federico II", Naples, Italy.

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