Clinical trial NCT05003505: Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection
Official title: Characteristics of Vaginal and Intestinal Microbiota in Women With Different Cervical HPV Infection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intestinal Microbiota
Vaginal Microbiota
HPV Infection
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 651
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese women aged 20-65 years with abnormal cervical cytology.

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.

Eligibility criteria: Inclusion Criteria:

* Women aged 20-65.
* TCT examination was performed in the last 3 months with abnormal results.
* Non pregnant people with sexual history.
* Asexual life, no vaginal medication or flushing before 72 hours of sampling.

Exclusion Criteria:

* Within 8 weeks after pregnancy or postpartum.
* Patients with history of genital tract tumor.
* History of HPV vaccination.
* Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
* In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
* Use antibiotics or vaginal microecological improvement products in recent 1 month.

Primary outcomes:
measure: Cervical histopathology testing at baseline
timeFrame: Baseline
measure: Cervical histopathology testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: Cervical histopathology testing at 24-month follow-up
timeFrame: 24-month follow-up
measure: Human Papillomavirus (HPV) DNA testing at baseline
timeFrame: baseline
measure: Human Papillomavirus (HPV) DNA testing at 6-month follow-up
timeFrame: 6-month follow-up
measure: Human Papillomavirus (HPV) DNA testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) DNA testing at 24-month follow-up
timeFrame: 24-month follow-up
measure: Cervical cytology testing at baseline
timeFrame: baseline
measure: Sequencing of the vaginal microbiota at baseline
timeFrame: baseline
measure: Sequencing of the vaginal microbiota at 6-month follow-up
timeFrame: 6-month follow-up
measure: Sequencing of the vaginal microbiota at 12-month follow-up
timeFrame: 12-month follow-up
measure: Sequencing of the vaginal microbiota at 24-month follow-up
timeFrame: 24-month follow-up
measure: Sequencing of the gut microbiota at baseline
timeFrame: baseline
measure: Sequencing of the gut microbiota at 6-month follow-up
timeFrame: 6-month follow-up
measure: Sequencing of the gut microbiota at 12-month follow-up
timeFrame: 12-month follow-up
measure: Untargeted Metabolites of vaginal secretions testing at baseline
timeFrame: baseline
measure: Change in vaginal secretions metabolome from baseline to 12-month follow-up assessments
timeFrame: 6-month follow-up and 12-month follow-up
measure: Serum metabolites testing at baseline
timeFrame: baseline
measure: Change in serum metabolome from baseline to 12-month follow-up assessments
timeFrame: 6-month follow-up and 12-month follow-up
Secondary outcomes:
measure: vaginal cytokine testing at enrollment
timeFrame: Enrollment
measure: vaginal cytokine testing at 6-month follow-up
timeFrame: 6-month follow-up
measure: vaginal cytokine testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: vaginal cytokine testing at 24-month follow-up
timeFrame: 24-month follow-up
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Ningde
country: China
facility: Mindong Hospital of Ningde City
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital Afflicated to Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou affiliated Hospital of Fujian Medical University
state: Fujian
city: Foshan
country: China
facility: Shunde Women's and Children's Hospital of Guangdong Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Maternal and Child Health Hospital of Shenzhen Province
state: Guangdong
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
name: Pengming Sun, PhD.
role: STUDY_CHAIR
References: