Clinical trial NCT02763696: Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota
Official title: Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota Which Overall Evaluation of Microscopic Precision Reference Standards
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginitis
Keywords: Metagenomics
Vaginal microflora
High-throughput sequencing
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child-bearing Woman

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 the"normal flora"of women of childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of the reference standard.


Eligibility criteria: 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

Primary outcomes:
measure: The use of High-throughput sequencing to establishment a sensitive system of the composition of vaginal Microbiota of normal Child-bearing Women
timeFrame: From the date of first normal woman who entered the subject to a whole menstrual cycles ended up to one month
measure: The use of High-throughput sequencing to comparison the composition of vaginal flora of normal women of childbearing age and women with vaginitis
timeFrame: From the date of one subjects entered to a whole menstrual cycles ended up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Yawen Wang, Ph.D
role: STUDY_CHAIR
References: