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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorIRCCS San Raffaele

About this trial

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 criteria

Qualifiers

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

Pap test: LSIL, ASC-US.

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

42 Participants
are divided into 2 treatment groups

Sponsors and collaborators