- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00576797
Genomic Tools for Studying the Ecology of the Human Vaginal Microflora (VM)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
-
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Maryland
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Baltimore, Maryland, United States, 21201
- Adolescent and Young Adult Center (AYAC),UMB
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Baltimore, Maryland, United States, 21201
- Center for Vaccine Development, University of Maryland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
descriptive analysis of vaginal microbiome
Time Frame: completed
|
completed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH
Time Frame: completed
|
completed
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacques Ravel, phD, University of Maryland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00001794
- U01AI070921-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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