A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- Onegevity Health
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Phenotype differences in DNA
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS.
Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women diagnosed with PCOS or Women who are considered Healthy
- •18-40 years old
- •Residing in the USA, except for exclusion states
- •Have not been using hormonal therapy for at least 3 months
Exclusion Criteria
- •Women using hormonal therapy within the last 3 months
- •Diagnosed with other significant health conditions or using medications that will affect hormone levels
- •Residing in NY, NJ, MD, RI, ND, SD, or HI
- •Pregnant or nursing
Outcomes
Primary Outcomes
Phenotype differences in DNA
Time Frame: Samples to be collected once per participant within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Saliva samples are to be collected and analyzed by a commercial laboratory for DNA and metabolomics.
Phenotype differences in gut microbiome
Time Frame: Samples to be collected once on any day per participant within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.
Phenotype differences in blood biomarkers
Time Frame: Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory, for a comprehensive analysis of targeted hormones and untargeted metabolic systems.
Phenotype differences in vaginal microbiome
Time Frame: Samples to be collected on any day once per participant within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Vaginal swabs are to be collected by women and analyzed with metagenomics and metabolomics sequencing.