Postmenopausal Women With Vaginal Microbiota

NCT ID: NCT03786601

Last Updated: 2019-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-25

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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HPV-Related Squamous Cell Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A,

High-risk HPV infection in postmenopausal women

Observation

Intervention Type OTHER

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

Group B

High-risk HPV negative in postmenopausal women

No interventions assigned to this group

Group C

High-risk HPV infection in gestational women

Observation

Intervention Type OTHER

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

Group D

High-risk HPV negative in gestational women

No interventions assigned to this group

Interventions

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Observation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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shuwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shu Wang

Role: CONTACT

+86-18810535568

Facility Contacts

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Hui Xu

Role: primary

+86-010-69156874

Other Identifiers

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PMWVM

Identifier Type: -

Identifier Source: org_study_id

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