Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota

NCT ID: NCT02763696

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-10

Study Completion Date

2018-12-31

Brief Summary

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The vaginal microbiota is an important biological barrier for host against pathogens or opportunistic pathogens. Undermining the balance of the vagina is closely related to infectious diseases and tumors.

The vaginal microbiota of child-bearing women of age is dominated by Lactobacillus species, including major four species: Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri and Lactobacillus iners, followed by obligate anaerobes such as Gardnerella vaginalis, Atopobium vaginae, Mobiluncus curtisii, and Prevotella .

Currently, There are almost 99% bacteria can not to be found with bacterial culture. Based on microscopy and conventional culture method to obtain vaginal microflora information have a variety of deviation. For this reason, The in-depth study of complex vaginal flora and the correct understanding of disease faces a serious obstacle. With the development of High-throughput sequencing technology, metagenomics can get all the composition and distribution of microorganisms from the sample which traditional knowledge may not be with microorganism culture method. Therefore, Re-evaluation of existing microflora diagnostic criteria for clinical diagnosis of the disease is necessary.

In this study, the investigators use high-throughput sequencing technology to detect women of childbearing age vaginal microflora of metagenomic distribution. Including bacteria, fungi, viruses, protozoa, and other microorganisms. Based on the study results of metagenomic, the investigators want to re-cognition the"normal flora"of women of childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of the reference standard.

Detailed Description

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Conditions

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Vaginitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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normal women

Composition of Viginal flora of Child-Bearing women in normal woman

Composition of Viginal flora of Child-Bearing women

Intervention Type OTHER

Use high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis

vaginitis women

Women of childbearing age with vaginitis

Composition of Viginal flora of Child-Bearing women

Intervention Type OTHER

Use high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis

Interventions

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Composition of Viginal flora of Child-Bearing women

Use high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Normal Child-bearing Women

Exclusion Criteria

* Pregnancy women
* Lactating women
* Using antibiotics or vaginal topical application of antibiotics over a month
* Have sexual activity in 3 days
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yawen Wang, Ph.D

Role: STUDY_CHAIR

First Affiliated Hospital of Xian Jiaotong University

Locations

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First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yawen Wang, Ph.D

Role: CONTACT

008613259935869

Facility Contacts

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Yawen Wang, Ph.D

Role: primary

008613259935869

Other Identifiers

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XJTU1AF-CRF-2015-009

Identifier Type: -

Identifier Source: org_study_id

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