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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03548740
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : February 6, 2019
Information provided by (Responsible Party):
shuwang, 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.

Condition or disease Intervention/treatment
Papillomavirus Infections 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 151 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine

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

Group B

Primary Outcome Measures :
  1. Vaginal microbiota and HR-HPV infection [ Time Frame: 12 months ]
    The persistence vaginal organism in HPV infection participants

  2. Vaginal microbiota and the cervical lesion [ Time Frame: 12 to 36 months ]
    The cervical cytology, HPV and the vaginal microbiota were evaluated

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03548740

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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Shu Wang, associated professor    +86-136-7124-6680   
Sponsors and Collaborators
Peking Union Medical College Hospital
Additional Information:

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Responsible Party: shuwang, Associate Professor, Peking Union Medical College Hospital Identifier: NCT03548740    
Other Study ID Numbers: WS-1
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections