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Sponsors and Collaborators: |
Emory University University of Maryland National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00576797 |
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 |
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Healthy |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Genomic Tools for Studying the Ecology of the Human Vaginal Microflora |
vaginal secretions
Estimated Enrollment: | 400 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2010 |
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
Ages Eligible for Study: | 12 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Asian, African American, Hispanic, or Cauasian women between the ages of 12 to 45 years old
Inclusion Criteria:
Exclusion Criteria:
Contact: Jacques Ravel, Ph.D | 410-706-6156 | |
Contact: Carol O Tacket, M.D | 410-706-6156 |
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. |
Principal Investigator: | Jacques Ravel, phD | University of Maryland |
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 |
vaginal bacteria microflora bacterial DNA To determine the normal bacteria in the vagina |
Healthy |