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

Papillomavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03548740
• Other study ID #: WS-1
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: May 20, 2020

Study information

• Verified date: February 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 151
• Est. completion date: May 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal microbiota and HR-HPV infection	The persistence vaginal organism in HPV infection participants	12 months
Primary	Vaginal microbiota and the cervical lesion	The cervical cytology, HPV and the vaginal microbiota were evaluated	12 to 36 months