VM: Genomic Tools for Studying the Ecology of the Human Vaginal Microflora

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT00576797

Collaborator

University of Maryland (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

396

Enrollment

Locations

Duration (Months)

132

Patients Per Site

16.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Healthy

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

Study Design

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 1, 2008

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

descriptive analysis of vaginal microbiome [completed]

Secondary Outcome Measures

correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH [completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	Adolescent and Young Adult Center (AYAC),UMB	Baltimore	Maryland	United States	21201
3	Center for Vaccine Development, University of Maryland	Baltimore	Maryland	United States	21201