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

• Published in: World journal of urology Vol. 39; no. 12; pp. 4373 - 4379
• Main Authors: Manfredi, Celeste, Calace, Francesco P., Fusco, Ferdinando, Quattrone, Carmelo, Giordano, Dario, Crocetto, Felice, Creta, Massimiliano, De Sio, Marco, Arcaniolo, Davide
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.12.2021; Springer Nature B.V
• Subjects: Adjuvant therapy; Adolescent; Adult; Adverse events; Anti-Bacterial Agents - therapeutic use; Antibiotics; Bacterial Infections - therapy; Chronic Disease; Combined Modality Therapy; E coli; Escherichia coli; Humans; Levofloxacin; Levofloxacin - therapeutic use; Male; Medicine; Medicine & Public Health; Middle Aged; Nephrology; Oncology; Oral administration; Original Article; Patients; Prostatitis; Prostatitis - microbiology; Prostatitis - therapy; Treatment Outcome; Urology; Young Adult; Fluoroquinolones; EcN; Microbiota; Chronic bacterial prostatitis; Nissle; Escherichia coli Nissle
• ISSN: 0724-4983; 1433-8726
• DOI: 10.1007/s00345-021-03773-8

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® 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. 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.