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Clinical Trials in Italy / NCT07697196
Starting soon Not applicable

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

NCT07697196 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Not applicable
Started
2026-07
Last updated
2026-07-13

Condition(s) studied

HPV InfectionHPV IntegrationHPV DiseaseHPV Genital InfectionHPV PersistenceLow Grade Squamous Intraepithelial Lesions of the Cervix

Investigational drug(s) / intervention(s)

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

Epigallocatechin gallate (EGCG), Folic Acid (FA), Vitamin B12 (B12), and Hyaluronic Acid (HA): Participants will self-administer one oral tablet of the dietary supplement Pervistop daily

Study summary

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.

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 25 years old 2. Positive HPV DNA test with genotyping 9-24 months prior to Day 0 3. Positive HPV DNA test with genotyping at Day 0 4. Presence of an HPV-related cervical lesion within 5-24 months prior to Day 0. This lesion will be defined alternatively as: 1. Pap test: LSIL, ASC-US. 2. Colposcopic impression suggestive of a low-grade lesion. 3. Histologic report of a colposcopic biopsy consistent with a low-grade lesion. 5. Previous HPV vaccination (latest dose at least 24 months earlier than Day 0) 6. Patients able to accept and sign informed consent for the study 7. Patients able to adhere to the proposed study protocol Exclusion Criteria: 1. High grade cervical lesions (HSIL) 2. Ongoing pregnancy, evaluated through a rapid chromatographic immunoassay for qualitative detection of hCG in urine 3. Ongoing breastfeeding 4. Primary or secondary immunodepression due to pharmacological treatments 5. No HPV vaccination 6. Daily assumption of other products containing green tea 7. Hypersensitivity or allergy to the substances contained in the supplement

Primary outcome measure(s)

  • Rate of clearance of viral oncoproteins E6 and E7 — 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffele Hospital Milan Italy

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Other trials for the same condition

The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07697196 on ClinicalTrials.gov ↗ ← All trials in Italy