Skip to main content
OpenTrials
Completed

NCT Number: NCT06804083

Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Prostatitis (CP) Chronic Prostatitis With Chronic Pelvic Pain Syndrome Chronic Prostatitis/ Pelvic Pain Syndrome Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatitis Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Molinette Hospital

Torino, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral combination of colostrum and Serenoa repens extracts (PROSTYM®)

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).

Drug administration (1 capsule per day) for 6 months.

Other names: PROSTYM®

Primary outcomes

  1. Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline

    Time frame: 6 months

    improvement of CP symptoms

Secondary outcomes

  1. Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline

    Time frame: 6 months

    improvement of CP pain symptoms

  2. Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline

    Time frame: 6 months

    improvement of CP QoL

  3. Total Number of Adverse Events

    Time frame: 6 months

    number and type, so safety analysis

Sponsors and collaborators

Lead sponsor

Clinica Urologica Molinette - Città della Saliute e della Scienza

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza - Molinette Hospital

Registry information

Official study title

Oral Immunoglobulins From Bovine Colostrum and Anti-inflammatory Extracts in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.