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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576797
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : February 2, 2016
University of Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Kevin Ault, MD, Emory University

Brief Summary:
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

Condition or disease

Detailed Description:

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

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Study Type : Observational
Actual Enrollment : 396 participants
Time Perspective: Prospective
Official Title: Genomic Tools for Studying the Ecology of the Human Vaginal Microflora
Study Start Date : May 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Primary Outcome Measures :
  1. descriptive analysis of vaginal microbiome [ Time Frame: completed ]

Secondary Outcome Measures :
  1. correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH [ Time Frame: completed ]

Biospecimen Retention:   Samples With DNA
vaginal secretions

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Asian, African American, Hispanic, or Cauasian women between the ages of 12 to 45 years old

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576797

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Adolescent and Young Adult Center (AYAC),UMB
Baltimore, Maryland, United States, 21201
Center for Vaccine Development, University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Emory University
University of Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Jacques Ravel, phD University of Maryland

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Responsible Party: Kevin Ault, MD, Principal Investigator, Emory University Identifier: NCT00576797     History of Changes
Other Study ID Numbers: IRB00001794
U01AI070921-01 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016

Keywords provided by Kevin Ault, MD, Emory University:
bacterial DNA
To determine the normal bacteria in the vagina