Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467942
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-02-17
Brief Title:
Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Effects of Estrogen-like Chinese Medicine and Vaginal Lactobacillus on HPV Clearance and Vaginal Microbiota Change in Women With Persistent HPV Infection
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELIMVLHPV
Brief 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
Detailed Description:
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
Traditional Chinese Medicine Group 10 days Lactobacillus Group 10 days Combination Group Traditional Chinese Medicine for 5 days Lactobacillus for 5 days Control Group Observation only no medication Pre-Treatment If applicable treat any existing vaginitis before assigning medications
Medication Regimen Administer 10 consecutive days of vaginal medication each month pausing during menstruation and resuming post-menstruation to complete the 10-day course Sexual intercourse is prohibited during the medication period
Follow-Up Testing Conduct CST HPV load and PAX1 methylation tests at 6 and 12 months post-treatment
Progression Monitoring If HPV remains positive upon retesting perform a colposcopy Terminate the study and provide appropriate treatment if pathology progresses to 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
Traditional Chinese Medicine Group 10 days Lactobacillus Group 10 days Combination Group Traditional Chinese Medicine for 5 days Lactobacillus for 5 days Control Group Observation only no medication Pre-Treatment If applicable treat any existing vaginitis before assigning medications
Medication Regimen Administer 10 consecutive days of vaginal medication each month pausing during menstruation and resuming post-menstruation to complete the 10-day course Sexual intercourse is prohibited during the medication period
Follow-Up Testing Conduct CST HPV load and PAX1 methylation tests at 6 and 12 months post-treatment
Progression Monitoring If HPV remains positive upon retesting perform a colposcopy Terminate the study and provide appropriate treatment if pathology progresses to HSIL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None