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NCT Number: NCT07697196

Effect of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on HPV DNA Integration

This interventional, single-center, open-label randomized clinical study evaluates the efficacy of an oral dietary supplement (Pervistop®) in women with persistent Human Papillomavirus (HPV) infection. The supplement is a combination of four natural molecules: Epigallocatechin gallate (EGCG), folic acid (FA), vitamin B12 (B12), and hyaluronic acid (HA).The primary objective is to describe the effect of this association on HPV DNA integration into the host genome by measuring the clearance rate of viral oncoproteins E6 and E7. A total of 42 women aged 25 or older with persistent HPV infection and low-grade cervical lesions will be randomized 1:1 into two groups. The treated group will receive one tablet of Pervistop® daily for six months, while the control group will follow standard clinical practice. The study aims to determine if this nutritional intervention can counteract viral persistence.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HPV Disease HPV Genital Infection HPV Integration HPV Persistence Infections Low Grade Squamous Intraepithelial Lesions of the Cervix Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Human Papillomavirus (HPV) is a common sexually transmitted infection that, while often regressing spontaneously, can persist. Persistent high-risk HPV infection is a major risk factor for cervical cancer because it allows viral DNA to integrate into the host genome. This integration triggers the constitutive expression of viral oncoproteins E6 and E7, which block the host's tumor suppressor genes (p53 and prb), leading to uncontrolled cell proliferation.Currently, clinical practice for low-grade lesions typically involves a surveillance approach. This study explores the use of a synergic combination of EGCG (anti-proliferative/pro-apoptotic), Vitamin B12 and Folic Acid (methylation agents), and Hyaluronic Acid (epithelial integrity) to promote viral clearance and inhibit E6/E7 expression.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 25 years old
  • Positive HPV DNA test with genotyping 9-24 months prior to Day 0
  • Positive HPV DNA test with genotyping at Day 0
  • Presence of an HPV-related cervical lesion within 5-24 months prior to Day 0. This lesion will be defined alternatively as:
  • Pap test: LSIL, ASC-US.
  • Colposcopic impression suggestive of a low-grade lesion.
  • Histologic report of a colposcopic biopsy consistent with a low-grade lesion.
  • Previous HPV vaccination (latest dose at least 24 months earlier than Day 0)
  • Patients able to accept and sign informed consent for the study
  • Patients able to adhere to the proposed study protocol

Exclusion criteria

  • High grade cervical lesions (HSIL)
  • Ongoing pregnancy, evaluated through a rapid chromatographic immunoassay for qualitative detection of hCG in urine
  • Ongoing breastfeeding
  • Primary or secondary immunodepression due to pharmacological treatments
  • No HPV vaccination
  • Daily assumption of other products containing green tea
  • Hypersensitivity or allergy to the substances contained in the supplement

Treatment and study plan

Epigallocatechin gallate (EGCG), Folic Acid (FA), Vitamin B12 (B12), and Hyaluronic Acid (HA)

Dietary Supplement

Participants will self-administer one oral tablet of the dietary supplement Pervistop daily

Primary outcomes

  1. Rate of clearance of viral oncoproteins E6 and E7

    Time frame: 6 months

    The percentage of participants showing a negative result for viral E6/E7 mRNA, which are key indicators of HPV DNA integration into the host genome. Analysis will be performed using the Aptima HPV assay, a transcription-mediated amplification (TMA) technique. A negative test result indicates viral clearance or loss of viral integration.

Secondary outcomes

  1. HPV DNA Clearance Rate

    Time frame: 6 months

    The rate of participants who test negative for high-risk HPV DNA using a multiplex PCR kit (Allplex II HPV 28 Detection). A negative result is defined as the absence of detectable high-risk HPV DNA above the analytical limit of detection

  2. Treatment Adherence score

    Time frame: 6 months

    Adherence to the oral supplementation protocol evaluated through the Morisky Medication Adherence Scale (MMAS-4) questionnaire

Other outcomes

  1. Quantitative Variation of E6/E7 Levels from baseline to T1

    Time frame: 6 months

    Variation of E6/E7 mRNA levels. Exploratory analysis of quantitative signals generated by the Aptima assay in the form of Relative Luminescent Units (RLU). The RLU value directly corresponds to the amount of target E6/E7 mRNA detected in the sample.

Study contacts

Contact information is provided by the study sponsor or research team.

Massimo Origoni, MD

CONTACT

[email protected]

+39 0226432759

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

An Interventional Study Evaluating the Effect of Epigallocatechin Gallate (EGCG), Folic Acid (FA), Vitamin B12 (B12) and Hyaluronic Acid (HA) in Affecting the DNA Integration of Human Papilloma Virus (HPV) in Women With Persistent Infection

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

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.

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