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

Vaginitis Clinical Trial

— ESSACWVM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02763696
• Other study ID #: XJTU1AF-CRF-2015-009
• Status: Recruiting
• Phase: N/A
• First received: April 26, 2016
• Last updated: March 23, 2017
• Start date: May 10, 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yawen Wang, Ph.D
• Phone: 008613259935869
• Email: wanglxy628[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaginitis

Intervention

Other:
• 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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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