Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection

NCT05003505 | Active Not Recruiting DMC

• 1 other identifier: CVMC2018
• Study Type: observational
• Target: 651
• Locations: 1 country
• Sites: 8

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.

Conditions

Intestinal Microbiota; Vaginal Microbiota; HPV Infection

Outcome Measures

Primary Outcomes (19)

• Cervical histopathology testing at baseline

  Cervical histopathology was performed at baseline for all participants.

  Baseline

• 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

• 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

• Human Papillomavirus (HPV) DNA testing at baseline

  All participants were tested for HPV DNA of cervical exfoliated cells at the time of baseline.

  baseline

• 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

• 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

• 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

• Cervical cytology testing at baseline

  All participants were tested for cervical cytology at the time of baseline.

  baseline

• Sequencing of the vaginal microbiota at baseline

  All participants underwent microbiological metagenomic sequencing of vaginal secretions at baseline.

  baseline

• 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

• 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

• 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

• Sequencing of the gut microbiota at baseline

  All participants underwent fecal microbiome sequencing at baseline.

  baseline

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• vaginal cytokine testing at enrollment

  Enrollment

• vaginal cytokine testing at 6-month follow-up

  6-month follow-up

• vaginal cytokine testing at 12-month follow-up

  12-month follow-up

• vaginal cytokine testing at 24-month follow-up

  24-month follow-up

Study Arms (1)

Women with cervical cytology (TCT) abnormalities

In the enrollment, women who have undergone cervical cytology (TCT) examination for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months, 12 months and 24 months.

Other: Follow up

Interventions

Follow up OTHER

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

Women with cervical cytology (TCT) abnormalities

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese women aged 20-65 years with abnormal cervical cytology.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (8)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, 350001, China

Location

Mindong Hospital of Ningde City

Ningde, Fujian, 352000, China

Location

Quanzhou First Hospital Afflicated to Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

Location

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363000, China

Location

Shunde Women's and Children's Hospital of Guangdong Medical University

Foshan, Guangdong, China

Location

Maternal and Child Health Hospital of Shenzhen Province

Shenzhen, Guangdong, China

Location

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA specimens of exfoliated cervix cells；DNA samples of vaginal secretions.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pengming Sun, PhD.

  Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory of Gynecologic Oncology

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 12, 2021
• Study Start: July 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (8)