Effects of Estrogen-like Chinese Medicine and Vaginal Lactobacillus on HPV Clearance and Vaginal Microbiota Change in Women With Persistent HPV Infection

ELIM-HPV2023

High risk human papillomavirus (hr-HPV) persistent infection is a high risk factor for cervical cancer. 85% to 90% of hr-HPV infections have the ability to clear on their own, while 10% to 15% of HPV persists further will lead to the development of high-grade intraepithelial lesions (HSIL) and even to invasive cervical cancer. Long-term follow-up results for persistent hr-HPV infection showed that cervical HSIL mostly occurred after 5-7 years of persistent hr-HPV infection, among which the risk of HPV16 and 18 was the highest, followed by HPV31 and 33. The role of the vaginal microbiome (CVM) in persistent hr-HPV infection has been increasingly valued, and women with persistent HPV infection that progresses to HSIL have a more unstable vaginal microenvironment. The previous study found that Lactobacillus vaginalis may contribute to HPV clearance by improving the vaginal microenvironment. In addition, previous studies have found that estrogen-like Chinese medicine could increase glycogen, improve mucosal estrogen levels, increase lactobacillus content, and promote HPV clearance. It is a challenge to make clinical management on when and how to intervene among hr-HPV persistent infection but whose pathology does not suggest HSIL. This study intends to analyze the correlation between the duration of HPV infection and the current vaginal microbiome, HPV load and PAX1 methylation in people with persistent HPV infection at different ages, and observe the changes of the above indicators after the administration of drugs to improve the vaginal microenvironment, which is helpful for preventing HPV persistent infection and developing into true precancerous lesions. It has the clinical and practical value of "preparing for a rainy day".

2023-03-01

2024-12-31

2024-12-31

Recruiting

240

Inclusion Criteria: * Women over 25 years of age with the same type of high-risk HPV infection lasting for more than 1 year, atypical squamous cell (ASCUS) or Low-grade squamous intraepithelial disease (LSIL) cytologically negative or undiagnosable, and pathological biopsy results negative or LSIL * Consent to use the device for contraception during the study period; * agree with medicine and follow-up management procedure. Exclusion Criteria: * High cytological risk, including atypical squamous cells (ASC-H),HSIL and atypical glandular cell (AGC), which could not rule out high-grade squamous intraepithelial lesions; * pathological biopsy for HSIL and above; * for any drug allergies; * pregnancy or lactation

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2024-06-21