Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection
NCT Number: NCT06467942
Acronym: ELIMVLHPV
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Human Papilloma Virus Infection
Interventions: DRUG: Chinese medicine and Lactobacillus|DRUG: Chinese medicine|DRUG: Lactobacillus
Sponsor: Peking University People's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2024-12-31
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China

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".

Primary Outcome Measures: community state type (CST), Vaginal microflora type, Change of CST at 6 months and 12 months after medication|HPV VL, HPV viral load, Change of HPV VL at 6 months and 12 months after medication|PAX1 methylation test, Pairing box gene1 methylation test, Change of PAX1 methylation test at 6 months and 12 months after medication
Secondary Outcome Measures: Complete remission (CR), HPV subtypes with persistent infection turned negative at 6 and 12 months or positive at 6 months, and negative at 12 months, Change of CR at 6 months and 12 months after medication|Partial remission (PR), Partial response (PR) : HPV subtypes with persistent infection turned negative at 6 months and returned positive at 12 months, Change of PR at 6 months and 12 months after medication|No response (NR), HPV subtypes with persistent infection were positive at both follow-up visits, Change of NR at 6 months and 12 months after medication