Genomic Tools for Studying the Ecology of the Human Vaginal Microflora (VM)

This study has been completed.
Sponsor:
Collaborators:
University of Maryland
Information provided by (Responsible Party):
Kevin Ault, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00576797
First received: December 17, 2007
Last updated: March 18, 2014
Last verified: March 2014
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Genomic Tools for Studying the Ecology of the Human Vaginal Microflora

Further study details as provided by Emory University:

Primary Outcome Measures:
  • descriptive analysis of vaginal microbiome [ Time Frame: completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH [ Time Frame: completed ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

vaginal secretions


Enrollment: 396
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Adolescent and Young Adult Center (AYAC),UMB
Baltimore, Maryland, United States, 21201
Center for Vaccine Development, University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Emory University
University of Maryland
Investigators
Principal Investigator: Jacques Ravel, phD University of Maryland
  More Information

No publications provided

Responsible Party: Kevin Ault, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00576797     History of Changes
Other Study ID Numbers: IRB00001794, U01AI070921-01
Study First Received: December 17, 2007
Last Updated: March 18, 2014
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

ClinicalTrials.gov processed this record on October 23, 2014