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

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

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

Conditions
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Vaginitis

Intervention / Treatment
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* Other: Composition of Viginal flora of Child-Bearing women


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal women<br>Composition of Viginal flora of Child-Bearing women in normal woman | Other: Composition of Viginal flora of Child-Bearing women<br>* Use high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis<br>|
| vaginitis women<br>Women of childbearing age with vaginitis | Other: Composition of Viginal flora of Child-Bearing women<br>* Use high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of High-throughput sequencing to establishment a sensitive system of the composition of vaginal Microbiota of normal Child-bearing Women |  | From 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 vaginitis |  | From the date of one subjects entered to a whole menstrual cycles ended up to one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metagenomics, Vaginal microflora, High-throughput sequencing