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Open Access 01-09-2021 | Prostatitis | Original Article

The use of Lactobacillus casei DG® prevents symptomatic episodes and reduces the antibiotic use in patients affected by chronic bacterial prostatitis: results from a phase IV study

Authors: Tommaso Cai, Luca Gallelli, Erika Cione, Gianpaolo Perletti, Francesco Ciarleglio, Gianni Malossini, Giovanni De Pretis, Alessandro Palmieri, Vincenzo Mirone, Riccardo Bartoletti, Truls E. Bjerklund Johansen

Published in: World Journal of Urology | Issue 9/2021

Abstract

Purpose

To evaluate the efficacy of Lactobacillus paracasei CNCM I-1572 (L. casei DG®) in both prevention of symptomatic recurrences and improvement of quality of life in patients with chronic bacterial prostatitis (CBP).

Methods

Patients with CBP attending a single Urological Institution were enrolled in this phase IV study. At enrollment, all patients were treated with antibiotics in agreement with EAU guidelines and then were treated with L. casei DG® (2 capsules/day for 3 months). Clinical and microbiological analyses were carried out before (enrollment, T0) and 6 months (T2) after the treatment. Both safety and adherence to the treatment were evaluated 3 months (T1) after the enrollment. NIH Chronic Prostatitis Symptom Index (CPSI), International Prostate Symptom Score (IPSS) and Quality of Well-Being (QoL) questionnaires were used. The outcome measures were the rate of symptomatic recurrence, changes in questionnaire symptom scores and the reduction of antibiotic use.

Results

Eighty-four patients were included. At T2, 61 patients (72.6%) reported a clinical improvement of symptoms with a return to their clinical status before symptoms. A time dependent improvement in clinical symptoms with significant changes in NIH-CPSI, IPSS and QoL (mean difference T2 vs T0: 16.5 ± 3.58; − 11.0 ± 4.32; + 0.3 ± 0.09; p < 0.001), was reported. We recorded that L. casei DG® treatment induced a statistically significant decrease in both (p < 0.001) symptomatic recurrence [1.9/3 months vs 0.5/3 months] and antibiotic use [− 7938 UDD]. No clinically relevant adverse effects were reported.

Conclusions

L. casei DG® prevents symptomatic recurrences and improves the quality of life in patients with CBP, reducing the antibiotic use.

Bartoletti R, Cai T, Mondaini N et al (2007) Prevalence, incidence estimation, risk factors and characterization of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy: results of a multi center case-control observational study. J Urol 178(6):2411–2415CrossRef

Bartoletti R, Cai T, Nesi G, Albanese S, Meacci F, Mazzoli S, Naber K. (2014) The impact of biofilm-producing bacteria on chronic bacterial prostatitis treatment: results from a longitudinal cohort study.World J Urol 32(3):737–742.

Magri V, Boltri M, Cai T, Colombo R, Cuzzocrea S, De Visschere P, Giuberti R, Granatieri CM, Latino MA, Larganà G, Leli C, Maierna G, Marchese V, Massa E, Matteelli A, Montanari E, Morgia G, Naber KG, Papadouli V, Perletti G, Rekleiti N, Russo GI, Sensini A, Stamatiou K, Trinchieri A, Wagenlehner FME (2019) Multidisciplinary approach to prostatitis. Arch Ital Urol Androl 90(4):227–248CrossRef

Penna G, Mondaini N, Amuchastegui S, Degli Innocenti S, Carini M, Giubilei G, Fibbi B, Colli E, Maggi M, Adorini L (2007) Seminal plasma cytokines and chemokines in prostate inflammation: interleukin 8 as a predictive biomarker in chronic prostatitis/chronicpelvicpainsyndrome and benignprostatichyperplasia. Eur Urol 51(2):524–533CrossRef

Cai T, Verze P, La Rocca R, Palmieri A, Tiscione D, Luciani LG, Mazzoli S, Mirone V, Malossini G (2017) The Clinical Efficacy of Pollen Extract and Vitamins on Chronic Prostatitis/Chronic Pelvic Pain Syndrome Is Linked to a Decrease in the Pro-Inflammatory Cytokine Interleukin-8. World J Mens Health 35(2):120–128CrossRef

Tsilingiri K, Barbosa T, Penna G et al (2012) Probiotic and postbiotic activity in health and disease: comparison on a novel polarised ex-vivo organ culture model. Gut 61:1007–1015CrossRef

Compare D, Rocco A, Coccoli P, Angrisani D, Sgamato C, Iovine B, Salvatore U, Nardone G (2017) Lactobacillus Casei DG and Its Postbiotic Reduce the Inflammatory Mucosal Response: An Ex-Vivo Organ Culture Model of Post-Infectious Irritable Bowel Syndrome. BMC Gastroenterol 17(1):53CrossRef

Vicari E, La Vignera S, Castiglione R, Condorelli RA, Vicari LO, Calogero AE (2014) Chronic Bacterial Prostatitis and Irritable Bowel Syndrome: Effectiveness of Treatment With Rifaximin Followed by the Probiotic VSL#3. Asian J Androl 16(5):735–739CrossRef

Cai T, Mazzoli S, Bechi A et al (2009) Serenoarepens associated with Urticadioica (ProstaMEV) and curcumin and quercitin (FlogMEV) extracts are able to improve the efficacy of prulifloxacin in bacterial prostatitis patients: results from a prospective randomised study. Int J Antimicrob Agents 33(6):549–553CrossRef

10.

Trinchieri A. Role of levofloxacin in the treatment of urinary tract infections. Arch Ital UrolAndrol2001;73:105–13.

11.

Bonkat G, Bartoletti R, Cai T et al. EAU guidelines on urological infections (2019). https://uroweb.org/guideline/urological-infections

12.

Monnet DL, Mölstad S, Cars O (2004) Defined daily doses of antimicrobials reflect antimicrobial prescriptions in ambulatory care. J AntimicrobChemother 53(6):1109–1111

13.

Cai T, Pisano F, Nesi G, Magri V, Verze P, Perletti G, Gontero P, Mirone V, Bartoletti R (2017) Chlamydia trachomatis versus common uropathogens as a cause of chronic bacterial prostatitis: is there any difference? results of a prospective parallel-cohort study. Investig Clin Urol 58(6):460–467CrossRef

14.

Gallelli L, Ferreri G, Colosimo M, Pirritano D, Flocco MA, Pelaia G, Maselli R, De Sarro GB (2003) Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro. Italy Pharmacol Res 47(6):493–499CrossRef

15.

Giubilei G, Mondaini N, Crisci A, Raugei A, Lombardi G, Travaglini F et al (2005) The Italian version of the National Institutes of Health Chronic prostatitis symptom index. Eur Urol 47:805–811CrossRef

16.

Badia X, Garcia-Losa M, Dal-Re R (1997) Ten-language translation and harmonizationof the International Prostate Symptom Score: developing a methodology for multinational clinical trials. Eur Urol 31:129–140CrossRef

17.

Kaplan RM, Bush JW, Berry CC: Health status: types of validity and the index of wellbeing. Health Serv Res 1976;11: 478–507

18.

Nickel JC, Downey J, Hunter D, Clark J (2001) Prevalence of prostatitis-like symptoms population based study using the National Institutes of Health chronic prostates symptoms index. J Urol 165:843–845

19.

David LA, Maurice CF, Carmody RN et al (2014) Diet rapidly and reproducibly alters the human gut microbiome. Nature 505:559–563. https://doi.org/10.1038/nature12820CrossRef

20.

Porter CM, Shrestha E, Peiffer LB, Sfanos KS (2018) The microbiome in prostate inflammation and prostate cancer. Prostate Cancer Prostatic Dis 21(3):345–354CrossRef

21.

Chiancone F, Carrino M, Meccariello C, Pucci L, Fedelini M, Fedelini P.The Use of a Combination of Vaccinium Macracarpon, Lyciumbarbarum L. and Probiotics (Bifiprost®) for the Prevention of Chronic Bacterial Prostatitis: A Double-Blind Randomized Study.Urol Int. 2019;103(4):423–426.

22.

Camilleri M (2006) Probiotics and irritable bowel syndrome: rationale, putative mechanisms, and evidence of clinical efficacy. J Clin Gastroenterol 40:264–269CrossRef

23.

Ferrario C, Taverniti V, Milani C, Fiore W, Laureati M, De Noni I, Stuknyte M, Chouaia B, Riso P, Guglielmetti S (2014) Modulation of Fecal Clostridiales Bacteria and Butyrate by Probiotic Intervention with Lactobacillus paracasei DG Varies among Healthy Adults. J Nutr 144(11):1787–1796CrossRef

24.

Cremon C, Guglielmetti S, Gargari G, Taverniti V, Castellazzi AM, Valsecchi C, Tagliacarne C, Fiore W, Bellini M, Bertani L, Gambaccini D, Cicala M, Germanà B, Vecchi M, Pagano I, Barbaro MR, Bellacosa L, Stanghellini V, Barbara G (2018) Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial. United European Gastroenterol J. 6(4):604–613CrossRef

25.

Balzaretti S, Taverniti V, Guglielmetti S, Fiore W, Minuzzo M,Ngo HN, Ngere JB, Sadiq S, Humphreys PN, Laws AP. A novel rhamnose-rich hetero-exopolysaccharide isolated from Lactobacillus paracasei DG activates THP-1 human monocytic cells. Appl Environ Microbiol. 2017; 17;83(3). pii: e02702–16

26.

Paoluzi OA, Del Vecchio BG, Visconti E, Coppola M, Fontana C, Favaro M, Pallone F (2015) Low efficacy of levofloxacin-doxycycline-based third-line triple therapy for Helicobacter pylori eradication in Italy. World J Gastroenterol 21(21):6698–6705CrossRef

27.

Bjerklund Johansen TE, Grüneberg RN, Guibert J, Hofstetter A, Lobel B, Naber KG et al (1998) The role of antibiotics in the treatment of chronic prostatitis: a consensus statement. Eur Urol 34:457–466CrossRef

28.

Thomas Jaeger and Ravi Deshpande. Choosing a Phase IV Study Design. Phase 4 Health Inc. Canadian Pharmaceutical Marketing/Winter 2003 available at: http://www.stacommunications.com/journals/pdfs/cpm/cpmwinter03/phasefour.pdf

Title: The use of Lactobacillus casei DG® prevents symptomatic episodes and reduces the antibiotic use in patients affected by chronic bacterial prostatitis: results from a phase IV study
Authors: Tommaso Cai
Luca Gallelli
Erika Cione
Gianpaolo Perletti
Francesco Ciarleglio
Gianni Malossini
Giovanni De Pretis
Alessandro Palmieri
Vincenzo Mirone
Riccardo Bartoletti
Truls E. Bjerklund Johansen
Publication date: 01-09-2021
Publisher: Springer Berlin Heidelberg
Keywords: Prostatitis
Probiotics
Antibiotic
Published in: World Journal of Urology / Issue 9/2021
Print ISSN: 0724-4983
Electronic ISSN: 1433-8726
DOI: https://doi.org/10.1007/s00345-020-03580-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The use of Lactobacillus casei DG® prevents symptomatic episodes and reduces the antibiotic use in patients affected by chronic bacterial prostatitis: results from a phase IV study

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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