Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection

NCT ID: NCT06467942

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Human Papilloma Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

observation group

Observation and follow-up only, no medication

Group Type: NO_INTERVENTION

No interventions assigned to this group

combined drug group

Chinese medicine 5 days + Lactobacillus 5 days

Group Type: EXPERIMENTAL

Chinese medicine and Lactobacillus

Intervention Type: DRUG

combined drug group

Single Chinese medicine group

Chinese medicine group 10 days

Group Type: ACTIVE_COMPARATOR

Chinese medicine

Intervention Type: DRUG

Single Chinese medicine group

Single Lactobacillus group

Lactobacillus group: 10 days

Group Type: ACTIVE_COMPARATOR

Lactobacillus

Intervention Type: DRUG

Single Lactobacillus group

Interventions

Chinese medicine and Lactobacillus

combined drug group

Intervention Type: DRUG

Chinese medicine

Single Chinese medicine group

Intervention Type: DRUG

Lactobacillus

Single Lactobacillus group

Intervention Type: DRUG

Other Intervention Names

Baofukang and Dingjunsheng; Baofukang; Dingjunsheng

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mingzhu Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingzhu Li

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hosptial

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingzhu Li, doctor

Role: CONTACT

mingzhu1815@163.com

86+15910691947

Facility Contacts

Mingzhu Li

Role: primary

Other Identifiers

ELIM-HPV2023

Identifier Type: -

Identifier Source: org_study_id