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

NCT02763696 | Unknown

• 1 other identifier: XJTU1AF-CRF-2015-009
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginitis

Keywords

Metagenomics; Vaginal microflora; High-throughput sequencing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

normal women

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

Other: Composition of Viginal flora of Child-Bearing women

vaginitis women

Women of childbearing age with vaginitis

Other: Composition of Viginal flora of Child-Bearing women

Interventions

Composition of Viginal flora of Child-Bearing women OTHER

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

normal women; vaginitis women

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Child-bearing Woman

You may qualify if:

• Normal Child-bearing Women

You may not qualify if:

• Pregnancy women
• Lactating women
• Using antibiotics or vaginal topical application of antibiotics over a month
• Have sexual activity in 3 days

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal secretions from Child-bearing Women

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yawen Wang, Ph.D

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

Central Study Contacts

Yawen Wang, Ph.D

CONTACT

008613259935869; wanglxy628@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 5, 2016
• Study Start: May 10, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

CN (1)