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

X

Xi'an Jiaotong University

Status

Unknown

Conditions

Vaginitis

Treatments

Other: Composition of Viginal flora of Child-Bearing women

Study type

Observational

Funder types

Other

Identifiers

NCT02763696
XJTU1AF-CRF-2015-009

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

normal women
Description:
Composition of Viginal flora of Child-Bearing women in normal woman
Treatment:
Other: Composition of Viginal flora of Child-Bearing women
vaginitis women
Description:
Women of childbearing age with vaginitis
Treatment:
Other: Composition of Viginal flora of Child-Bearing women

Trial contacts and locations

1

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Central trial contact

Yawen Wang, Ph.D

Data sourced from clinicaltrials.gov

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