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临床试验/NCT06467942
NCT06467942招募中不适用

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

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
community state type (CST)

研究概览

简要总结

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".

详细描述

  1. Correlation of Previous Persistent HPV Infection Duration with Current CST, HPV Load, and PAX1 Methylation Participants: Select 240 women aged 25 and above who have had persistent high-risk HPV infection of the same type for 1 year or more but whose pathology does not indicate HSIL.

Data Recording: Record the time of first confirmed HPV infection based on test reports.

Initial Testing: After meeting the inclusion criteria, conduct initial tests for vaginal microbiota types (CST), HPV load, and PAX1 methylation.

Correlation Analysis: Analyze the correlations based on different ages, menopausal status, and duration of HPV infection. 2. Changes in CST, HPV Load, and PAX1 Methylation After Treatment to Improve Vaginal Microenvironment

Study Design: Conduct a double-blind randomized medication trial with the participants divided into four groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

combined drug group

Experimental

Chinese medicine 5 days + Lactobacillus 5 days

干预措施: Chinese medicine and Lactobacillus (Drug)

Single Chinese medicine group

Active Comparator

Chinese medicine group 10 days

干预措施: Chinese medicine (Drug)

Single Lactobacillus group

Active Comparator

Lactobacillus group: 10 days

干预措施: Lactobacillus (Drug)

结局指标

主要结局

community state type (CST)

时间窗: Change of CST at 6 months and 12 months after medication

Vaginal microflora type

HPV VL

时间窗: Change of HPV VL at 6 months and 12 months after medication

HPV viral load

PAX1 methylation test

时间窗: Change of PAX1 methylation test at 6 months and 12 months after medication

Pairing box gene1 methylation test

次要结局

  • Complete remission (CR)(Change of CR at 6 months and 12 months after medication)
  • No response (NR)(Change of NR at 6 months and 12 months after medication)
  • Partial remission (PR)(Change of PR at 6 months and 12 months after medication)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mingzhu Li

Principal Investigator

Peking University People's Hospital

研究点 (1)

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