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

Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.

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.

Study Overview

• Status: Unknown
• Conditions: Papillomavirus Infections
• Intervention / Treatment: Biological: Human Papillomavirus

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 Type: Observational
• Enrollment (Anticipated): 151

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A	Biological: Human Papillomavirus; women with high-risk Human Papillomavirus or not
Group B

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): January 20, 2020
• Study Completion (Anticipated): May 20, 2020

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: WS-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No