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Genomic Tools for Studying the Ecology of the Human Vaginal Microflora (VM)

This study has been completed.
Sponsor:
Collaborators:
University of Maryland
Information provided by (Responsible Party):
Kevin Ault, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00576797
First received: December 17, 2007
Last updated: March 18, 2014
Last verified: March 2014

December 17, 2007
March 18, 2014
May 2008
January 2009   (final data collection date for primary outcome measure)
descriptive analysis of vaginal microbiome [ Time Frame: completed ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00576797 on ClinicalTrials.gov Archive Site
correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH [ Time Frame: completed ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Genomic Tools for Studying the Ecology of the Human Vaginal Microflora
Genomic Tools for Studying the Ecology of the Human Vaginal Microflora

The human vagina contains a large number of normal bacteria. These bacteria are important because provide protection against other bacteria that may cause disease. Several important diseases are linked to abnormal bacteria in the vagina. Women with abnormal bacteria in the vagina are more likely to be infected with human immunodeficiency virus, the virus that causes AIDS. Also women with unusual bacteria in their vagina are more likely to deliver a premature baby when they are pregnant. For these reasons, it is important to have a better understanding of the normal bacteria of the vagina.Some bacteria found in the vagina can not be grown in a laboratory. Our preliminary studies indicate a very wide variety of bacteria in the vagina. Also we have shown there are some differences between African American and Caucasian women. The goal of our study is to study the bacteria in the vagina of normal women using the latest technology. This technology involves study the bacterial DNA present in the normal microbes in the vagina

The normal vaginal bacteria in healthy women of reproductive age plays a key role in preventing successful colonization by "undesirable" organisms including those responsible for bacterial vaginosis, yeast infections, sexually transmitted diseases and urinary tract infections. Our long-term goal is to develop an accurate understanding of the vagina microbial ecosystem in normal, healthy women as an essential prerequisite for comprehending how the normal microflora reduces the risk of acquiring these common vaginal infections.

Four hundred women will be recruited such that there will be equal distribution among four self-declared ethnic groups (Caucasian, African-American, Hispanic and Asian). These groupings were selected based on the original Forney study that identified different distributions supergroups of dominant vaginal microflora between African-American and Caucasian women.

The experimental focus of this proposal is to use a combination of culture-independent methods (T-RFLP of 16S rRNA, 16SrRNA and recA genes sequence analysis and community genomics) to develop tools aimed at advancing our understanding of the composition and role of individual organisms and communities that make up the ecosystems of human vaginas . The specific aims are designed to develop genomic tools for the research and clinical scientific community to study the ecology of the human vaginal microflora

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

vaginal secretions

Non-Probability Sample

Asian, African American, Hispanic, or Cauasian women between the ages of 12 to 45 years old

Healthy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
396
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between the ages of 12 and 45
  • Regular menstrual cycles from 21 to 35 days long
  • Normal healthy volunteer
  • Negative urine pregnancy test
  • Ability to understand and sign informed consent

Exclusion Criteria:

  • Used douches, vaginal medications or suppositories, feminine sprays, genital wipes, or contraceptive spermicides in the past 48 hours
  • Sexually active in the past 48 hours (involving female genitalia)
  • Pregnancy (by history or testing)
  • Use of antibiotics or antifungal drugs within the past 30 days
  • Have chronic illnesses such as kidney failure, diabetes or HIV/AIDS
  • Self-reported vaginal discharge in the past 48 hours
  • Currently menstruating
  • Currently participating in a drug or treatment clinical research trial
  • Received a vaccine within the last 30 days
  • Received a vaccine against a bacterial infection
  • Currently using NuvaRing for contraception
  • Any other condition that in the opinion of the investigator would place the subject in unacceptable risk for participation in the study
Female
12 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576797
IRB00001794, U01AI070921-01
No
Kevin Ault, MD, Emory University
Emory University
  • University of Maryland
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Jacques Ravel, phD University of Maryland
Emory University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP