Genomic Tools for Studying the Ecology of the Human Vaginal Microflora



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:12 - 45
Updated:4/21/2016
Start Date:May 2008
End Date:January 2009

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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

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
We found this trial at
3
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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