Chronic Prostatitis (CP)Phase 4NCT06804083

Bovine Colostrum Efficacy for the Treatment of Chronic Prostatitis Symptoms.

A Phase 4 study testing oral combination of colostrum and Serenoa repens extracts (PROSTYM®) in people with Chronic Prostatitis (CP) and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Clinica Urologica Molinette - Città della Saliute e della Scienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Chronic Prostatitis (CP), Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis/ Pelvic Pain Syndrome
What is being tested?: oral combination of colostrum and Serenoa repens extracts (PROSTYM®)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteItaly
Study dates: 1 Mar 2020to 30 Jun 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Molinette Hospital
Torino, Torino, 10126

Other trials in Italy

About this study

Official title: 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.

Conditions: Chronic Prostatitis (CP), Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis/ Pelvic Pain Syndrome
Being tested: oral combination of colostrum and Serenoa repens extracts (PROSTYM®)
Keywords: Chronic prostatitis, chronic pelvic pain syndrome, PROSTYM®, bovine colostrum, LUTS, pain
Medical subject headings: Prostatitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral combination of colostrum and Serenoa repens extracts (PROSTYM®)Drug
Also called 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.

Study groups in NCT06804083
Study group	Role	What they receive
PROSTYM®	Experimental	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. Receives: Drug: oral combination of colostrum and Serenoa repens extracts (PROSTYM®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline
improvement of CP symptoms
Measured: 6 months

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202030 Jun 2023

First posted31 Jan 2025
Study start1 Mar 2020
Primary completion31 Dec 2022
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic Prostatitis (CP)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: prospective, observational, single-arm study
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06804083
Sponsor's protocol ID: CET n. 00054/2019
Status last verified: Jan 2025
First submitted: 8 Jan 2025
Last updated: 31 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19524353
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.
PubMed 10411041
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.
PubMed 23334883
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.
PubMed 31937091

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Pelvic Pain Syndrome (CPPS)
Not yet recruiting
Acupuncture for Erectile Dysfunction
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions
Recruiting
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
Chronic Prostatitis
Not yet recruiting
Extracorporeal Shock-Wave Therapy (ESWT) vs Phytotherapy vs Combined in Treatment of Chronic Prostatitis
Chronic Prostatitis (CP)

All Chronic Prostatitis (CP) trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Immunoglobulins From Bovine Colostrum and Anti-inflammatory Extracts in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Study
ClinicalTrials.gov ID: NCT06804083
Acronym / sponsor ID: CET n. 00054/2019
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Clinica Urologica Molinette - Città della Saliute e della ScienzaUniversity, hospital or other
Collaborators: A.O.U. Città della Salute e della Scienza - Molinette Hospital
Study start: 1 Mar 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 31 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: prospective, observational, single-arm study

Arm	Type	Receives
PROSTYM®	Experimental	Drug: oral combination of colostrum and Serenoa repens extracts (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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oral combination of colostrum and Serenoa repens extracts (PROSTYM®)Also: 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.	Drug	PROSTYM®

Primary outcome

Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline
Time frame: 6 months
improvement of CP symptoms

3 secondary outcomes

Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline
Time frame: 6 months
Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline
Time frame: 6 months
Total Number of Adverse Events
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Results publication: PubMed 19524353Wagenlehner 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.
Results publication: PubMed 10411041Litwin 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.
Results publication: PubMed 23334883Cai 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.
Results publication: PubMed 31937091Sibona 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.
Individual participant dataSharing planned: No

Related trials for Chronic Prostatitis (CP)

RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Pelvic Pain Syndrome (CPPS)
Not yet recruiting
Acupuncture for Erectile Dysfunction
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Erectile Dysfunctions
Recruiting
TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS
Chronic Prostatitis
Not yet recruiting
Extracorporeal Shock-Wave Therapy (ESWT) vs Phytotherapy vs Combined in Treatment of Chronic Prostatitis
Chronic Prostatitis (CP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06804083, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.