Baseline Study of Vaginal Microbiota in Healthy Chinses Female Population (BSOVM)

April 9, 2024 updated by: Peking Union Medical College Hospital
The reproductive tract microecology is an important part of the human microbial system. Microorganisms and the host reproductive tract environment form a stable symbiotic relationship. When pathogens invade or microecology imbalance，it can lead to serious reproductive tract infection.Reproductive tract infection is one of the most common disease among women，and it is a global social and public health problem. Reproductive tract infection is characterized by high morbidity, low cure rate and high recurrence rate.Data from the studies shows that 40% of Chinese women suffer from reproductive tract infections of varying degrees, that is, at least 200 million. Long-term chronic infections can lead to serious consequences such as infertility, tumor, abortion and premature birth. At present, the diagnostic classification of reproductive tract infection is mainly divided into Aerobic vaginitis（AV), Bacterial vaginosis（BV), Vulvovaginal candidiasis（VVC) and Trichomonas vaginitis（TV). The reproductive tract microbiota is complex, but the clinical classification is relatively simple, which makes the treatment lack of precision. More precise treatment，permanent cure and reducing the recurrence rate are the top priorities in the field of medical and health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At present, the treatment of vaginitis is dominated by anti-pathogen medicine. While killing pathogenic microorganisms, it also inhibits the growth of normal vaginal lactobacillus, which further aggravates the vaginal microecological imbalance and makes it the root of refractory, drug-resistant and recurrent reproductive tract infections.

A growing number of studies show that the key point of the treatment for reproductive tract infections is to adjust the proportion of vaginal microorganism composition, in order to achieve the initial Lactobacillus dominant state, and maintaining the balance of vaginal microecology .

The composition and proportion of microorganisms in the lower reproductive tract influenced by a variety of factors, such as changes in sex hormone levels and phases of the menstrual cycle, sexual activity, antibiotic treatment and use of oral contraceptives, vaginal irrigation, menopause, pregnancy, breastfeeding, diabetes and stress . Also, there are obvious differences between different ethnicities and regions . Therefore, we need to conduct correlation analysis on the microbiota structure and various indicators of the Chinese population, and develop a more reasonable method for classifying lower reproductive tract infections and treatments. According to this classification method, accurate diagnosis of vaginal disease is further carried out, more rational treatment options can be implemented，and the health of patients is effectively improved.

Based on the above background, the study collected DNA from vaginal secretions from about 10,000 healthy Chinese women of reproductive age. And the DNA was tested by next genetic sequencing.The data obtained in this project will establish the baseline of the lower reproductive tract microbiome of Chinese population, and will be used for future research and comparison. The results will be used to explore the comparison of the lower reproductive tract flora of the population in different regions of China, and of the Chinese population with other ethnicities worldwide.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The comparison of the lower reproductive tract flora of the population in different regions of China, and of the Chinese population with other ethnicities worldwide.

Description

Inclusion Criteria:

  • Women of childbearing age who are physically and mentally healthy, have regular menstruation and are between 20-45 years old;
  • Women who are evaluated as normal by vaginal microbiome morphological characterization;
  • Women who agree to participate in this study and have signed an informed consent form;
  • Those who have full capacity for civil and legal conduct;
  • The quality of vaginal samples meets the evaluation requirements of this program.

Exclusion Criteria:

  • The sampling quality of vaginal secretions does not meet the research study requirements;
  • The quality or format of the slide collection of vaginal smears does not meet the requirements;
  • Women with severe physical or mental illness;
  • Users of hormone therapy and antibiotic drugs;
  • Women with insufficient compliance with this study;
  • Women who are participating in other coinciding clinical drug or medical device trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal women group
I. Women of childbearing age who are physically and mentally healthy, have regular menstruation and are between 20-45 years old; II. Women who are evaluated as normal by vaginal microbiome morphological characterization; III. Women who agree to participate in this study and have signed an informed consent form; IV. Those who have full capacity for civil and legal conduct; V. The quality of vaginal samples meets the evaluation requirements of this program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nugent score
Time Frame: 1 year
The morphological manifestations of vaginal microflora were observed by the examiner under the microscope, and the vaginal microecological results were evaluated according to the Nugent score.Nugent Scoring System（0-10）for Gram-Stained Vaginal Smears Total Score：0-3 Normal； 4-6 Intermediate；7-10 Bacterial Vaginosis
1 year
Next generation sequencing
Time Frame: 1 year
16s rRNA gene sequencing and metagenomic sequencing
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Lan Zhu, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-2902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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