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

Overview

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.

Full Title of Study: “Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 20, 2020

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.

Interventions

  • Biological: Human Papillomavirus
    • women with high-risk Human Papillomavirus or not

Arms, Groups and Cohorts

  • Group A
  • Group B

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: shuwang, Associate Professor – Peking Union Medical College Hospital

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