Effect of a Dietary Supplement Containing EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid in Supporting Male Genital Balance in Subjects Exposed to HPV Risk

Обзор

Pilot interventional study aimed at evaluating the effect of a dietary supplement containing EGCG, vitamin B12, hyaluronic acid, and folic acid on the maintenance of physiological balance of the genital mucosa and natural defenses of the male genital tract, as well as on the maintenance of HPV-DNA test negativity, in subjects undergoing natural procreation pathways. The study will also assess the potential support of sperm parameters, reproductive well-being of the couple, and the reduction of risk factors associated with HPV transmission to the female partner. A total of 34 HPV-positive couples attending the Istituto Scientifico Internazionale "Paolo VI" of the Policlinico A. Gemelli will be enrolled and randomized into two groups: 17 couples in the intervention group, in which the male partner will receive the supplement (EGCG 200 mg, vitamin B12 1 mg, hyaluronic acid 50 mg, folic acid 400 μg, one tablet daily for 6 months), and 17 couples in the control group with no supplementation.

Подробное описание

This pilot, randomized interventional study aims to assess the effect of a dietary supplement containing epigallocatechin gallate (EGCG), vitamin B12, hyaluronic acid, and folic acid on the maintenance of physiological balance and natural defenses of the male genital tract in men with HPV infection attending natural procreation centers. The study also seeks to evaluate whether supplementation may support sperm quality, improve reproductive well-being of participating couples, and reduce risk factors associated with HPV transmission to the female partner.

A total of 48 couples (96 participants) will be enrolled at the Istituto Scientifico Internazionale "Paolo VI" of the Policlinico A. Gemelli. Eligible couples, characterized by an HPV-positive male partner and an HPV-negative female partner, will be randomized into two groups: a supplement group, in which both partners will receive oral supplementation with EGCG (200 mg), vitamin B12 (1 mg), hyaluronic acid (50 mg), and folic acid (400 μg) once daily for 6 months, and a control group receiving no supplementation. Randomization will be performed using a computer-generated list.

The primary endpoint is the proportion of male participants achieving a negative HPV DNA test at the end of the 6-month intervention period. Secondary endpoints include changes in sperm quality parameters assessed by semen analysis according to WHO 2021 guidelines, measures of reproductive outcomes such as fertility potential and achievement of pregnancy, and maintenance of genital mucosal health, including absence of infections or recurrences and reduced risk of HPV transmission. HPV genotyping will be assessed by PCR on urethral swab samples. The overall study duration is expected to be 18 months following ethics committee approval.

Вмешательства

• Пищевая добавка pervistop
  combination of EGCG, vitamin B12, hyaluronic acid, and folic acid

Первичные конечные точки

• Negative HPV-DNA test [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Signed informed consent
• Couple seeking pregnancy
• Male partner aged 25-65 years
• HPV DNA test indicating active HPV infection in the male partner
• HPV DNA test indicating negativity for HPV infection in the female partner

Критерии исключения

• Concomitant diseases causing immunosuppression
• Treatment with immunomodulatory therapies
• Use of EGCG or other green tea extracts

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Porcaro, G.; Pavone-Cossut, M.R.; Moretti, S.; Bilotta, G.; Aragona, C.; Unfer, V. Oral Treatment with EGCG, Folic Acid, Vitamin B12, and Hyaluronic Acid Improves HPV Clearance and Counteracts Its Persistence: A Clinical Study. 2025, 26, 5251. https://doi.org/10.3390/ijms26115251. 42. Weinberg M, Sar-Shalom Nahshon C, Feferkorn I, Bornstein J. Evaluation of human papilloma virus in semen as a risk
• Tinelli A, Gustapane S, Licchelli M, Coluccia AC, Panese G, Proietti S, Gambioli R. Treatment with Epigallocatechin Gallate, Folic Acid, Vitamin B12, and Hyaluronic Acid Decreases HPV Positivity in Women Attending Regional Screening in Puglia. Microorganisms. 2024 Sep 14;12(9):1897. doi: 10.3390/microorganisms12091897. PMID 39338571
• Aragona C, Bezerra Espinola MS, Bilotta G, Porcaro G, Calcagno M. Evaluating the Efficacy of Pervistop(R), a New Combination Based on EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on Patients with Human Papilloma Virus (HPV) Persistent Infections and Cervical Lesions: A Pilot Study. J Clin Med. 2023 Mar 10;12(6):2171. doi: 10.3390/jcm12062171. PMID 36983172
• Ono A, Koshiyama M, Nakagawa M, Watanabe Y, Ikuta E, Seki K, Oowaki M. The Preventive Effect of Dietary Antioxidants on Cervical Cancer Development. Medicina (Kaunas). 2020 Nov 10;56(11):604. doi: 10.3390/medicina56110604. PMID 33182663
• Kwanbunjan K., Saengkar P., Cheeramakara C., Thanomsak W., Benjachai W.,Laisupasin P., Buchachart K., Songmuaeng K., Boontaveeyuwat N. Low folate status as a risk factor for cervical dysplasia in Thai women. Nutr. Res. 2005;25:641-654. doi: 10.1016/j.nutres.2005.05.004.
• Hernandez BY, McDuffie K, Wilkens LR, Kamemoto L, Goodman MT. Diet and premalignant lesions of the cervix: evidence of a protective role for folate, riboflavin, thiamin, and vitamin B12. Cancer Causes Control. 2003 Nov;14(9):859-70. doi: 10.1023/b:caco.0000003841.54413.98. PMID 14682443
• Piyathilake CJ, Henao OL, Macaluso M, Cornwell PE, Meleth S, Heimburger DC, Partridge EE. Folate is associated with the natural history of high-risk human papillomaviruses. Cancer Res. 2004 Dec 1;64(23):8788-93. doi: 10.1158/0008-5472.CAN-04-2402. PMID 15574793
• Piyathilake CJ, Macaluso M, Chambers MM, Badiga S, Siddiqui NR, Bell WC, Edberg JC, Partridge EE, Alvarez RD, Johanning GL. Folate and vitamin B12 may play a critical role in lowering the HPV 16 methylation-associated risk of developing higher grades of CIN. Cancer Prev Res (Phila). 2014 Nov;7(11):1128-37. doi: 10.1158/1940-6207.CAPR-14-0143. Epub 2014 Aug 21. PMID 25145486

Идентификаторы

NCT: NCT07320183 · 8299

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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