Genomic Tools for Studying the Ecology of the Human Vaginal Microflora

NCT00576797 | Completed

• 2 other identifiers: IRB00001794U01AI070921-01
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 3

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

Conditions

Healthy

Keywords

vaginal; bacteria; microflora; bacterial DNA; To determine the normal bacteria in the vagina

Outcome Measures

Primary Outcomes (1)

• descriptive analysis of vaginal microbiome

  completed

Secondary Outcomes (1)

• correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH

  completed

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Asian, African American, Hispanic, or Cauasian women between the ages of 12 to 45 years old

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• University of Maryland: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

Adolescent and Young Adult Center (AYAC),UMB

Baltimore, Maryland, 21201, United States

Location

Center for Vaccine Development, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

vaginal secretions

Study Officials

• Jacques Ravel, phD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: May 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

US (3)