Longitudinal Analysis of the Vaginal Microbiome
- Conditions
- Vaginal Microbiome
- Registration Number
- NCT05383326
- Lead Sponsor
- Viome
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
- Biological sex is female
- Willing to collect own vaginal samples
- Willing to answer health questions
- Experience menstrual cycles regularly (a monthly cycle)
- Pregnant
- Antibiotic use in the past 3 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of vaginal microbial functions 1 year A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions
Identification of vaginal microbial taxonomy 1 year A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Viome Life Sciences
🇺🇸Bothell, Washington, United States