Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection

HPV Infection Clinical Trial

Official title:

Characteristics of Vaginal and Intestinal Microbiota in Women With Different Cervical HPV Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05003505
• Other study ID #: CVMC2018
• Status: Active, not recruiting
• Start date: July 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: Fujian Maternity and Child Health Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 651
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HPV Infection
• Infections
• Intestinal Microbiota
• Papillomavirus Infections
• Vaginal Microbiota

Intervention

Other:
• Follow up
Participants will be followed up at 6, 12 and 24 months with the test of enous blood, vaginal secretions, faeces, and cervical exfoliated cells.

Locations

Country	Name	City	State
China	Shunde Women's and Children's Hospital of Guangdong Medical University	Foshan	Guangdong
China	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian
China	Mindong Hospital of Ningde City	Ningde	Fujian
China	Quanzhou First Hospital Afflicated to Fujian Medical University	Quanzhou	Fujian
China	Maternal and Child Health Hospital of Shenzhen Province	Shenzhen	Guangdong
China	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei
China	Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	Zhangzhou affiliated Hospital of Fujian Medical University	Zhangzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical histopathology testing at baseline	Cervical histopathology was performed at baseline for all participants.	Baseline
Primary	Cervical histopathology testing at 12-month follow-up	Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.	12-month follow-up
Primary	Cervical histopathology testing at 24-month follow-up	Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.	24-month follow-up
Primary	Human Papillomavirus (HPV) DNA testing at baseline	All participants were tested for HPV DNA of cervical exfoliated cells at the time of baseline.	baseline
Primary	Human Papillomavirus (HPV) DNA testing at 6-month follow-up	All participants were tested for HPV DNA of cervical exfoliated cells at the time of 6-month follow-up.	6-month follow-up
Primary	Human Papillomavirus (HPV) DNA testing at 12-month follow-up	All participants were tested for HPV DNA of cervical exfoliated cells at the time of 12-month follow-up.	12-month follow-up
Primary	Human Papillomavirus (HPV) DNA testing at 24-month follow-up	All participants were tested for HPV DNA of cervical exfoliated cells at the time of 24-month follow-up.	24-month follow-up
Primary	Cervical cytology testing at baseline	All participants were tested for cervical cytology at the time of baseline.	baseline
Primary	Sequencing of the vaginal microbiota at baseline	All participants underwent microbiological metagenomic sequencing of vaginal secretions at baseline.	baseline
Primary	Sequencing of the vaginal microbiota at 6-month follow-up	All participants underwent microbiological metagenomic sequencing of vaginal secretions at 6-month follow-up.	6-month follow-up
Primary	Sequencing of the vaginal microbiota at 12-month follow-up	All participants underwent microbiological metagenomic sequencing of vaginal secretions at 12-month follow-up.	12-month follow-up
Primary	Sequencing of the vaginal microbiota at 24-month follow-up	All participants underwent microbiological metagenomic sequencing of vaginal secretions at 24-month follow-up.	24-month follow-up
Primary	Sequencing of the gut microbiota at baseline	All participants underwent fecal microbiome sequencing at baseline.	baseline
Primary	Sequencing of the gut microbiota at 6-month follow-up	All participants underwent fecal microbiome sequencing at 6-month follow-up.	6-month follow-up
Primary	Sequencing of the gut microbiota at 12-month follow-up	All participants underwent fecal microbiome sequencing at 12-month follow-up.	12-month follow-up
Primary	Untargeted Metabolites of vaginal secretions testing at baseline	All participants were tested for microbial untargeted metabolites of vaginal secretions at baseline by liquid chromatography tandem mass spectrometric (LC-MS). Measure abundances of vaginal secretions metabolites, metabolic networks, and metabolic pathways activity.	baseline
Primary	Change in vaginal secretions metabolome from baseline to 12-month follow-up assessments	All participants were tested for microbial metabolites of vaginal secretions at 6-month follow-up and 12-month follow-up by LC-MS. Change in vaginal secretions metabolome from baseline to 12-month follow-up were assessed.	6-month follow-up and 12-month follow-up
Primary	Serum metabolites testing at baseline	All participants were tested for serum metabolites at enrollment by LC-MS. Measure abundances of serum metabolites, metabolic networks, and metabolic pathways activity.	baseline
Primary	Change in serum metabolome from baseline to 12-month follow-up assessments	All participants were tested for microbial metabolites of serum at 6-month follow-up and 12-month follow-up by LC-MS. Change in serum metabolome from baseline to 12-month follow-up were assessed.	6-month follow-up and 12-month follow-up
Secondary	vaginal cytokine testing at enrollment	All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1ß (pg/ml) and other cytokines in vaginal secretions at enrollment.	Enrollment
Secondary	vaginal cytokine testing at 6-month follow-up	All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1ß (pg/ml) and other cytokines in vaginal secretions at 6-month follow-up.	6-month follow-up
Secondary	vaginal cytokine testing at 12-month follow-up	All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1ß (pg/ml) and other cytokines in vaginal secretions at 12-month follow-up.	12-month follow-up
Secondary	vaginal cytokine testing at 24-month follow-up	All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1ß (pg/ml) and other cytokines in vaginal secretions at 24-month follow-up.	24-month follow-up