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Genomic Tools for Studying the Ecology of the Human Vaginal Microflora (VM)
This study is currently recruiting participants.
Verified by Emory University, August 2008
Sponsors and Collaborators: Emory University
University of Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00576797
  Purpose

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
Healthy

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Genomic Tools for Studying the Ecology of the Human Vaginal Microflora

Further study details as provided by Emory University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

vaginal secretions


Estimated Enrollment: 400
Study Start Date: May 2008
Estimated Study Completion Date: June 2010
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

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576797

Contacts
Contact: Jacques Ravel, Ph.D 410-706-6156
Contact: Carol O Tacket, M.D 410-706-6156

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Shara Karlebach, NP     404-778-4169     shara.karlebach@emory.edu    
Contact: Kevin Ault, MD     404-686-5500 ext 14937     kault@emory.edu    
Principal Investigator: Kevin Ault, MD            
United States, Maryland
Center for Vaccine Development, University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Carol O. Tacket, M.D.     410-706-6156        
Contact: Jacques Ravel     410-706-6156        
Principal Investigator: Carol Tacket, M.D            
Adolescent and Young Adult Center (AYAC),UMB Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ligia Peralta, M.D.     410-706-4153        
Contact: Jacques Ravel, Ph.D.     410-706-6156        
Principal Investigator: Ligia Peralta, M.D.            
Sponsors and Collaborators
Emory University
University of Maryland
Investigators
Principal Investigator: Jacques Ravel, phD University of Maryland
  More Information

Responsible Party: University of Maryland ( Jacques Ravel, phD )
Study ID Numbers: U01AI070921-01
Study First Received: December 17, 2007
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00576797  
Health Authority: United States: Federal Government;   United States: Institutional Review Board

Keywords provided by Emory University:
vaginal
bacteria
microflora
bacterial DNA
To determine the normal bacteria in the vagina

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009