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

Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota Which Overall Evaluation of Microscopic Precision Reference Standards

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02763696
Acronym
ESSACWVM
Enrollment
50
Registered
2016-05-05
Start date
2016-05-10
Completion date
2018-12-31
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginitis

Keywords

Metagenomics, Vaginal microflora, High-throughput sequencing

Brief summary

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 thenormal floraof women of childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of the reference standard.

Interventions

OTHERComposition 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

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The use of High-throughput sequencing to establishment a sensitive system of the composition of vaginal Microbiota of normal Child-bearing WomenFrom the date of first normal woman who entered the subject to a whole menstrual cycles ended up to one month
The use of High-throughput sequencing to comparison the composition of vaginal flora of normal women of childbearing age and women with vaginitisFrom the date of one subjects entered to a whole menstrual cycles ended up to one month

Countries

China

Contacts

Primary ContactYawen Wang, Ph.D
wanglxy628@sina.com008613259935869

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026