Longitudinal Analysis of the Vaginal Microbiome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Identification of vaginal microbial functions
Study Overview
Brief Summary
This is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. This study is direct to participant and will NOT utilize clinical sites.
Detailed Description
Eligible women will be recruited into the study. They will be consented and asked to complete a health questionnaire. On six separate days during two menstrual cycles, they will be asked to collect vaginal swab samples (total of 12). For each sample collection, they will answer the sample collection questionnaire. Samples will be returned to Viome labs for analysis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Biological sex is female
- •Willing to collect own vaginal samples
- •Willing to answer health questions
- •Experience menstrual cycles regularly (a monthly cycle)
Exclusion Criteria
- •Antibiotic use in the past 3 months
Outcomes
Primary Outcomes
Identification of vaginal microbial functions
Time Frame: 1 year
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions
Identification of vaginal microbial taxonomy
Time Frame: 1 year
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy
Secondary Outcomes
No secondary outcomes reported