Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection (ELIMVLHPV)

June 15, 2024 updated by: Mingzhu Li, Peking University People's Hospital

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

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".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Mingzhu Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: observation group
Observation and follow-up only, no medication
Experimental: combined drug group
Chinese medicine 5 days + Lactobacillus 5 days
Drug: Chinese medicine and Lactobacillus
combined drug group
Other Names:
  • Baofukang and Dingjunsheng
Active Comparator: Single Chinese medicine group
Chinese medicine group 10 days
Drug: Chinese medicine
Single Chinese medicine group
Other Names:
  • Baofukang
Active Comparator: Single Lactobacillus group
Lactobacillus group: 10 days
Drug: Lactobacillus
Single Lactobacillus group
Other Names:
  • Dingjunsheng

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
community state type (CST)
Time Frame: Change of CST at 6 months and 12 months after medication
Vaginal microflora type
Change of CST at 6 months and 12 months after medication
HPV VL
Time Frame: Change of HPV VL at 6 months and 12 months after medication
HPV viral load
Change of HPV VL at 6 months and 12 months after medication
PAX1 methylation test
Time Frame: Change of PAX1 methylation test at 6 months and 12 months after medication
Pairing box gene1 methylation test
Change of PAX1 methylation test at 6 months and 12 months after medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission (CR)
Time Frame: Change of CR at 6 months and 12 months after medication
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)
Time Frame: Change of PR at 6 months and 12 months after medication
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)
Time Frame: Change of NR at 6 months and 12 months after medication
HPV subtypes with persistent infection were positive at both follow-up visits
Change of NR at 6 months and 12 months after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Mingzhu Li, Peking University People's Hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 15, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELIM-HPV2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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