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

• Conditions: Papillomavirus Infections
• Interventions: Biological: Human Papillomavirus

• Registration Number: NCT03548740
• Lead Sponsor: Peking Union Medical College Hospital

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.

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.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-07
• Study Start: 2018-09-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-06
• Primary Completion: 2020-01-20
• Study Completion: 2020-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 151

Inclusion Criteria

Clinical diagnosis of HR-HPV results.

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Human Papillomavirus	-

Primary Outcome Measures

Name	Time	Method
Vaginal microbiota and HR-HPV infection	12 months	The persistence vaginal organism in HPV infection participants
Vaginal microbiota and the cervical lesion	12 to 36 months	The cervical cytology, HPV and the vaginal microbiota were evaluated

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China