HealthyVMNCT00576797
Genomic Tools for Studying the Ecology of the Human Vaginal Microflora
An observational study of Healthy, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 396 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Asian, African American, Hispanic, or Cauasian women between the ages of 12 to 45 years old
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
Adolescent and Young Adult Center (AYAC),UMB
Baltimore, Maryland, 21201
Center for Vaccine Development, University of Maryland
Baltimore, Maryland, 21201
About this study
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
Read the 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
- Conditions
- Healthy
- Keywords
- vaginal, bacteria, microflora, bacterial DNA, To determine the normal bacteria in the vagina
What is being measured
The primary outcome is the main question the study is designed to answer.
descriptive analysis of vaginal microbiome
Measured: completed
Secondary outcomes (1)
correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH
Measured: completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Kevin Ault, MD, Emory University
- Investigators
- Jacques Ravel, phD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576797
- Sponsor's protocol ID
- IRB00001794
- Other IDs
- U01AI070921-01
- Acronym
- VM
- Status last verified
- Feb 2016
- First submitted
- 17 Dec 2007
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Tools for Studying the Ecology of the Human Vaginal Microflora
- ClinicalTrials.gov ID
- NCT00576797
- Acronym / sponsor ID
- VM / IRB00001794
- Conditions
- Healthy
- Keywords
- vaginal, bacteria, microflora, bacterial DNA, To determine the normal bacteria in the vagina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Asian, African American, Hispanic, or Cauasian women between the ages of 12 to 45 years old
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
descriptive analysis of vaginal microbiome
Time frame: completed
1 secondary outcome
correlate vaginal microbiome to other demographic information, Nugent score and vaginal pH
Time frame: completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Ravel, phD principal investigator
University of Maryland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descriptive analysis of vaginal microbiome (time frame: completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.