CClinicalTrials.gg
Status unknownNCT03548740Updated Feb 6, 2019

Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection

An observational study in Papillomavirus Infections, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to female participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-06.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
151
Ages
25 Years to 50 Years
Sex
Female
01

Study summary

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.

Read the detailed description

Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 151 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Group A: HPV positive, and the participants who have not taken drugs and physical therapy in the past six months, nor have chronic diseases (such as DM), take their vaginal microorganisms (do not mention the past History issues). Group B: HPV negative in the past 12 months, taking the vaginal microorganisms.

Inclusion criteria

Clinical diagnosis of HR-HPV results.

Exclusion criteria

Exclusion Criteria:

Clinical diagnosis of vaginitis, immune disease, malignancy History of cervical lesions Pregnancy Clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction Severe mental illness

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
151 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Group A

    Biological: Human Papillomavirus

  • Group B

Interventions

  • BiologicalHuman Papillomavirus

    women with high-risk Human Papillomavirus or not

06

What researchers measure

Primary outcomes

  1. Vaginal microbiota and HR-HPV infection

    The persistence vaginal organism in HPV infection participants

    Time frame: 12 months

  2. Vaginal microbiota and the cervical lesion

    The cervical cytology, HPV and the vaginal microbiota were evaluated

    Time frame: 12 to 36 months

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03548740
Lead sponsor
Peking Union Medical College Hospital
Responsible party
shuwang (Associate Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Jun 7, 2018
Start date
Sep 1, 2018
Primary completion
Jan 20, 2020 (estimated)
Completion
May 20, 2020 (estimated)
Last update
Feb 6, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion