Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection

Human Papilloma Virus Infection Clinical Trial

— ELIMVLHPV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467942
• Other study ID #: ELIM-HPV2023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Peking University People's Hospital
• Contact: Mingzhu Li, doctor
• Phone: 86+15910691947
• Email: mingzhu1815[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Human Papilloma Virus Infection
• Infections
• Papilloma
• Papillomavirus Infections

Intervention

Drug:
• Chinese medicine and Lactobacillus
combined drug group
• Chinese medicine
Single Chinese medicine group
• Lactobacillus
Single Lactobacillus group

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	community state type (CST)	Vaginal microflora type	Change of CST at 6 months and 12 months after medication
Primary	HPV VL	HPV viral load	Change of HPV VL at 6 months and 12 months after medication
Primary	PAX1 methylation test	Pairing box gene1 methylation test	Change of PAX1 methylation test at 6 months and 12 months after medication
Secondary	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
Secondary	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
Secondary	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