Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection

NCT06467942 | Recruiting DMC

• 1 other identifier: ELIM-HPV2023
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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".

Conditions

Human Papilloma Virus Infection

Outcome Measures

Primary Outcomes (3)

• community state type (CST)

  Vaginal microflora type

  Change of CST at 6 months and 12 months after medication

• HPV VL

  HPV viral load

  Change of HPV VL at 6 months and 12 months after medication

• PAX1 methylation test

  Pairing box gene1 methylation test

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

Secondary Outcomes (3)

• Complete remission (CR)

  Change of CR at 6 months and 12 months after medication

• Partial remission (PR)

  Change of PR at 6 months and 12 months after medication

• No response (NR)

  Change of NR at 6 months and 12 months after medication

Study Arms (4)

observation group

NO INTERVENTION

Observation and follow-up only, no medication

combined drug group

EXPERIMENTAL

Chinese medicine 5 days + Lactobacillus 5 days

Drug: Chinese medicine and Lactobacillus

Single Chinese medicine group

ACTIVE COMPARATOR

Chinese medicine group 10 days

Drug: Chinese medicine

Single Lactobacillus group

ACTIVE COMPARATOR

Lactobacillus group: 10 days

Drug: Lactobacillus

Interventions

Chinese medicine and Lactobacillus DRUG

combined drug group

Also known as: Baofukang and Dingjunsheng

combined drug group

Chinese medicine DRUG

Single Chinese medicine group

Also known as: Baofukang

Single Chinese medicine group

Lactobacillus DRUG

Single Lactobacillus group

Also known as: Dingjunsheng

Single Lactobacillus group

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: physical examination was female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingzhu Li

  Peking University People's Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhu Li, doctor

CONTACT

86+15910691947; mingzhu1815@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: June 21, 2024
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)