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RECRUITING
NCT06467942
NA

Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

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".

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

Key Details

Gender

FEMALE

Age Range

25 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-03-01

Completion Date

2024-12-31

Last Updated

2024-06-21

Healthy Volunteers

No

Interventions

DRUG

Chinese medicine and Lactobacillus

combined drug group

DRUG

Chinese medicine

Single Chinese medicine group

DRUG

Lactobacillus

Single Lactobacillus group

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China