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Postmenopausal Women With Vaginal Microbiota

High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03786601
Enrollment
1
Registered
2018-12-26
Start date
2018-12-25
Completion date
2020-07-01
Last updated
2019-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV-Related Squamous Cell Carcinoma

Brief 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 in postmenopausal women.

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. Owing to the decrease of estrogen level and cervical atrophy in postmenopausal women, cervical cytology is more prone to abnormal changes than in premenopausal women. Clinically, cervical lesions in elderly women are easily neglected. Therefore, cervical cancer in the elderly is usually found in advanced stage, with poor prognosis and more complications of treatment. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions in menopausal women. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

Interventions

OTHERObservation

The participants were assigned to different groups according to the results of HPV detection.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 75 Years

Inclusion criteria

* Those are aged 20 to 75 years old, have had vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.

Exclusion criteria

* Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.

Design outcomes

Primary

MeasureTime frameDescription
Vaginal microbiota and HR-HPV infection in menopausal women6 monthsThe persistence vaginal organism in HPV infection menopausal women

Secondary

MeasureTime frameDescription
The difference of vaginal microbiota in different age groups6 monthsThe difference of vaginal microbiota in different age groups with HR-HPV infection

Countries

China

Contacts

Primary ContactShu Wang
chaoxp_pumch@163.com+86-18810535568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026