Clinical trial NCT06804083: Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.
Official title: Oral Immunoglobulins From Bovine Colostrum and Anti-inflammatory Extracts in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Prostatitis (CP)
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Chronic Prostatitis/ Pelvic Pain Syndrome
Keywords: Chronic prostatitis
chronic pelvic pain syndrome
PROSTYM®
bovine colostrum
LUTS
pain
Lead sponsor: Clinica Urologica Molinette - Città della Saliute e della Scienza
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
First posted: 2025-01-31
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, observational, single-arm study
Primary purpose: TREATMENT

Brief summary: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition.

The aim of this study was to investigate the role of an oral combination of colostrum and Serenoa repens extracts (PROSTYM®) in the treatment of CP/CPPS patients. The main questions the present study aims to answer are:

* Does PROSTYM® enhance quality of life of CPP/CPPS patients?
* Does it help reducing pain symptoms of CPP/CPPS patients?

Researchers will investigate whether PROSTYM® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.

Participants will:

* Take PROSTYM® every day for 6 months;
* Visit the clinic for follow-up visits at 3 and 6 months;
* Answer validated questionnaires and declare potential adverse events at follow-up visits.


Eligibility criteria: Inclusion Criteria:

* adult male patients (aged \>18 years)
* clinical affection by CP/CPPS with symptoms that persisted for ≥6 months;
* CPSI pain domain score ≥5 points;
* negative Meares and Stamey test score.

Exclusion Criteria:

* patients with prevalent BPH symptoms (CPSI pain domain \<5), acute prostatitis, chronic bacterial prostatitis (positive Meares and Stamey test), prostate or bladder cancer, urethral stenosis or neurological bladder;
* no other drug or supplement specific to chronic prostatitis in the previous 30 days.

Primary outcomes:
measure: Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline
timeFrame: 6 months
Secondary outcomes:
measure: Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline
timeFrame: 6 months
measure: Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline
timeFrame: 6 months
measure: Total Number of Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Molinette Hospital
Study officials:
References:
citation: Wagenlehner FM, Schneider H, Ludwig M, Schnitker J, Brahler E, Weidner W. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: a multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study. Eur Urol. 2009 Sep;56(3):544-51. doi: 10.1016/j.eururo.2009.05.046. Epub 2009 Jun 3.
citation: Litwin MS, McNaughton-Collins M, Fowler FJ Jr, Nickel JC, Calhoun EA, Pontari MA, Alexander RB, Farrar JT, O'Leary MP. The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network. J Urol. 1999 Aug;162(2):369-75. doi: 10.1016/s0022-5347(05)68562-x.
citation: Cai T, Luciani LG, Caola I, Mondaini N, Malossini G, Lanzafame P, Mazzoli S, Bartoletti R. Effects of pollen extract in association with vitamins (DEPROX 500(R)) for pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome: results from a pilot study. Urologia. 2013 Apr 24;80 Suppl 22:5-10. doi: 10.5301/RU.2013.10597. Epub 2013 Jan 16.
citation: Sibona M, Destefanis P, Agnello M, Lillaz B, Giuliano M, Cai T, Gontero P. The association of Boswellia resin extract and propolis derived polyphenols can improve quality of life in patients affected by prostatitis-like symptoms. Arch Ital Urol Androl. 2020 Jan 14;91(4):251-255. doi: 10.4081/aiua.2019.4.251.