PMID- 34213584 OWN - NLM STAT- MEDLINE DCOM- 20220224 LR - 20220224 IS - 1433-8726 (Electronic) IS - 0724-4983 (Linking) VI - 39 IP - 12 DP - 2021 Dec TI - Escherichia coli Nissle 1917 as adjuvant therapy in patients with chronic bacterial prostatitis: a non-blinded, randomized, controlled trial. PG - 4373-4379 LID - 10.1007/s00345-021-03773-8 [doi] AB - PURPOSE: To evaluate the efficacy and safety of Escherichia coli Nissle 1917 (EcN) in association with levofloxacin in patients with chronic bacterial prostatitis (CBP). METHODS: 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(R) 500 mg once daily for 4 weeks. Only the patients in Group B underwent oral administration of EcN(R) 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. RESULTS: 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. CONCLUSIONS: 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. CI - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Manfredi, Celeste AU - Manfredi C AD - Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. FAU - Calace, Francesco P AU - Calace FP AUID- ORCID: 0000-0002-6340-4403 AD - Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. frap.calace@gmail.com. FAU - Fusco, Ferdinando AU - Fusco F AD - Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. FAU - Quattrone, Carmelo AU - Quattrone C AD - Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. FAU - Giordano, Dario AU - Giordano D AD - Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. FAU - Crocetto, Felice AU - Crocetto F AD - Department of Urology, University "Federico II", Naples, Italy. FAU - Creta, Massimiliano AU - Creta M AD - Department of Urology, University "Federico II", Naples, Italy. FAU - De Sio, Marco AU - De Sio M AD - Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. FAU - Arcaniolo, Davide AU - Arcaniolo D AD - Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Via S. Pansini 5, Naples, 80131, Italy. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20210702 PL - Germany TA - World J Urol JT - World journal of urology JID - 8307716 RN - 0 (Anti-Bacterial Agents) RN - 6GNT3Y5LMF (Levofloxacin) SB - IM CIN - Nat Rev Urol. 2021 Aug;18(8):444. PMID: 34253903 MH - Adolescent MH - Adult MH - Anti-Bacterial Agents/*therapeutic use MH - Bacterial Infections/*therapy MH - Chronic Disease MH - Combined Modality Therapy MH - *Escherichia coli MH - Humans MH - Levofloxacin/*therapeutic use MH - Male MH - Middle Aged MH - Prostatitis/*microbiology/*therapy MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Chronic bacterial prostatitis OT - EcN OT - Escherichia coli Nissle OT - Fluoroquinolones OT - Microbiota EDAT- 2021/07/03 06:00 MHDA- 2022/02/25 06:00 CRDT- 2021/07/02 12:18 PHST- 2021/04/20 00:00 [received] PHST- 2021/06/21 00:00 [accepted] PHST- 2021/07/03 06:00 [pubmed] PHST- 2022/02/25 06:00 [medline] PHST- 2021/07/02 12:18 [entrez] AID - 10.1007/s00345-021-03773-8 [pii] AID - 10.1007/s00345-021-03773-8 [doi] PST - ppublish SO - World J Urol. 2021 Dec;39(12):4373-4379. doi: 10.1007/s00345-021-03773-8. Epub 2021 Jul 2.