Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT05003505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2021-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection
Sponsor:
Fujian Maternity and Child Health Hospital
Organization:
Study Overview
Official Title:
Characteristics of Vaginal and Intestinal Microbiota in Women With Different Cervical HPV Infection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are different microbial communities on the surface of human body (skin, hair, nails, etc.) and in the cavity connected with the outside world. The human microbiota is the general term of the genetic information of microorganisms that coexist with human beings and cause various diseases under certain conditions. The results of human microbial genome analysis show that the microbial communities in different parts of the human body and different individuals have amazing diversity, some of which play an important role in human health, and some are closely related to diseases. Female lower genital tract infection is often associated with human papillomavirus (HPV) infection and bacterial vaginosis (BV), such as cervical and vaginal precancerous lesions, cancer, condyloma acuminatum and other sexually transmitted diseases (STD). Persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. New evidence suggests that vaginal microbiota composition is different in women with HR-HPV infection and high-grade cervical lesions. The increase of the severity of cervical intraepithelial neoplasia is related to the decrease of the relative abundance of vaginal Lactobacillus. In addition to vaginal microbes, the powerful intestinal flora is considered to be the "invisible organ" of the human body. There is a dynamic and balanced interaction network between intestinal microorganisms and human immune cells. Once the intestinal flora is out of balance, the changes in species, quantity, proportion, location and biological characteristics will cause a series of inflammatory reactions and immune system diseases, and even lead to cancer. Some studies have shown that there is a potential relationship between intestinal microorganisms and vaginal microorganisms. Recent research evidence suggests that the mutually beneficial relationship between oral bacteria and other vaginal bacteria supports the colonization of pathogens and may help maintain the characteristics of vaginal flora imbalance.
Detailed Description:
Based on the clinical practice, this study carried out a multi center cohort study in Fujian Province, China. In this study, five research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University and Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University were included, each of which included 600 individuals, with a total of 3000 women with potential cervical lesions were enrolled. Blood samples were tested for immunology, stool swabs and vaginal secretions were collected for microecological evaluation. At the same time, 21 kinds of common HPV virus types, cervical exfoliative cytology and 10 kinds of common STDs pathogens were detected. The included population will be tested with the same samples at 6, 12 and 24 months of follow-up to explore the relationship between vaginal, intestinal microorganisms and cervical HPV infection and the development of cervical lesions and its potential impact, so as to further explore the key factors affecting the persistent infection and clearance of HPV in female reproductive tract and the potential impact factors of the occurrence and development of cervical lesions. This prospective observational the characteristics of vaginal and intestinal microbiota in women with different cervical HPV infection, to evaluate the relationship and the underlying effect in the developoing of cervical lessions.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: