Human Papilloma Virus InfectionELIMVLHPVNCT06467942
Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection
A study testing Chinese medicine and Lactobacillus, Chinese medicine and Lactobacillus in people with Human Papilloma Virus Infection, run by Peking University People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Human Papilloma Virus Infection
- What is being tested?
- Chinese medicine and Lactobacillus, Chinese medicine and Lactobacillus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Mingzhu Li
About this study
Official title: 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".
Read the detailed description
- 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.
- 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
- Being tested
- Chinese medicine and Lactobacillus, Chinese medicine, Lactobacillus
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese medicine and LactobacillusDrug
Also called Baofukang and Dingjunsheng
combined drug group
Chinese medicineDrug
Also called Baofukang
Single Chinese medicine group
LactobacillusDrug
Also called Dingjunsheng
Single Lactobacillus group
| Study group | Role | What they receive |
|---|---|---|
| observation group | No intervention | Observation and follow-up only, no medication |
| combined drug group | Experimental | Chinese medicine 5 days + Lactobacillus 5 days Receives: Drug: Chinese medicine and Lactobacillus |
| Single Chinese medicine group | Active comparator | Chinese medicine group 10 days Receives: Drug: Chinese medicine |
| Single Lactobacillus group | Active comparator | Lactobacillus group: 10 days Receives: Drug: Lactobacillus |
What is being measured
The primary outcome is the main question the study is designed to answer.
community state type (CST)
Vaginal microflora type
Measured: Change of CST at 6 months and 12 months after medication
HPV VL
HPV viral load
Measured: Change of HPV VL at 6 months and 12 months after medication
PAX1 methylation test
Pairing box gene1 methylation test
Measured: Change of PAX1 methylation test at 6 months and 12 months after medication
Secondary outcomes (3)
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
Measured: Change of CR at 6 months and 12 months after medication
Partial remission (PR)
Partial response (PR) : HPV subtypes with persistent infection turned negative at 6 months and returned positive at 12 months
Measured: Change of PR at 6 months and 12 months after medication
No response (NR)
HPV subtypes with persistent infection were positive at both follow-up visits
Measured: Change of NR at 6 months and 12 months after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingzhu Li, Peking University People's Hospital
- Investigators
- Mingzhu Li, Principal investigator, Peking University People's Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467942
- Sponsor's protocol ID
- ELIM-HPV2023
- Acronym
- ELIMVLHPV
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Estrogen-like Chinese Medicine and Vaginal Lactobacillus on HPV Clearance and Vaginal Microbiota Change in Women With Persistent HPV Infection
- ClinicalTrials.gov ID
- NCT06467942
- Acronym / sponsor ID
- ELIMVLHPV / ELIM-HPV2023
- Conditions
- Human Papilloma Virus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| observation group | No intervention | –Observation and follow-up only, no medication |
| combined drug group | Experimental | Drug: Chinese medicine and LactobacillusChinese medicine 5 days + Lactobacillus 5 days |
| Single Chinese medicine group | Active comparator | Drug: Chinese medicineChinese medicine group 10 days |
| Single Lactobacillus group | Active comparator | Drug: LactobacillusLactobacillus group: 10 days |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese medicine and LactobacillusAlso: Baofukang and Dingjunshengcombined drug group | Drug | combined drug group |
| Chinese medicineAlso: BaofukangSingle Chinese medicine group | Drug | Single Chinese medicine group |
| LactobacillusAlso: DingjunshengSingle Lactobacillus group | Drug | Single Lactobacillus group |
Primary outcome
community state type (CST)
Time frame: Change of CST at 6 months and 12 months after medication
Vaginal microflora type
HPV VL
Time frame: Change of HPV VL at 6 months and 12 months after medication
HPV viral load
PAX1 methylation test
Time frame: Change of PAX1 methylation test at 6 months and 12 months after medication
Pairing box gene1 methylation test
3 secondary outcomes
Complete remission (CR)
Time frame: 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
No response (NR)
Time frame: Change of NR at 6 months and 12 months after medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingzhu Li principal investigator
Peking University People's Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese medicine and Lactobacillus, Chinese medicine and Lactobacillus in people with Human Papilloma Virus Infection, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingzhu Li, doctor (86+15910691947, mingzhu1815@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
community state type (CST) (time frame: Change of CST at 6 months and 12 months after medication). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.