Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.

Oral Immunoglobulins from Bovine Colostrum and Anti-inflammatory Extracts in Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Prostatitis (CP); Chronic Prostatitis/ Pelvic Pain Syndrome; Chronic Prostatitis with Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Drug: oral combination of colostrum and Serenoa repens extracts (PROSTYM®)

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10126
    • Molinette Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PROSTYM®; It is a phytotherapic drug. The composition of PROSTYM® (per capsule) includes bovine colostrum (30 mg), Serenoa extracts (320 mg), glutathione (30 mg), N-acetyl cysteine (20 mg), Ribes nigrum extracts (50 mg), willow extracts (50 mg), zinc (5 mg), selenium (27.5 micrograms), and vitamin E (6 mg). All these components are included in one capsule. The drug is administered for 6 months in a 1 cp/die dosage.

Drug: oral combination of colostrum and Serenoa repens extracts (PROSTYM®); The composition of PROSTYM® (per capsule) includes bovine colostrum (30 mg), Serenoa extracts (320 mg), glutathione (30 mg), N-acetyl cysteine (20 mg), Ribes nigrum extracts (50 mg), willow extracts (50 mg), zinc (5 mg), selenium (27.5 micrograms), and vitamin E (6 mg). Drug administration (1 capsule per day) for 6 months.; Other Names: PROSTYM®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline	improvement of CP symptoms	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline	improvement of CP pain symptoms	6 months
Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline	improvement of CP QoL	6 months
Total Number of Adverse Events	number and type, so safety analysis	6 months

Collaborators and Investigators

• Sponsor: Clinica Urologica Molinette - Città della Saliute e della Scienza
• Collaborators: A.O.U. Città della Salute e della Scienza - Molinette Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pain; LUTS; chronic pelvic pain syndrome; Chronic prostatitis; bovine colostrum; PROSTYM®
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Mental Disorders; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Disease; Somatoform Disorders; Syndrome; Pelvic Pain; Chronic Disease; Prostatitis; Urological Agents; Saw palmetto extract
• Other Study ID Numbers: CET n. 00054/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No