Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with PCOS | Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues |
| |
| Healthy controls | Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention study | Other | This observational study will only collect data, not provide any intervention to participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phenotype differences in vaginal microbiome | 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. | Samples to be collected on any day once per participant within 30 days of enrollment |
| Phenotype differences in gut microbiome | 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. | Samples to be collected once on any day per participant within 30 days of enrollment |
| Phenotype differences in blood biomarkers | 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. | Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment |
| Phenotype differences in DNA | 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. | Samples to be collected once per participant within 30 days of enrollment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women, ages 18-40, living in the USA (except for NY, NJ, RI, MD, SD, ND, or HI), who have not been using hormonal therapy for at least 3 months and without other significant health issues or medications affecting hormones. Women must be previously diagnosed with PCOS or considered Healthy and not currently pregnant or nursing. Women will be referred to the study by their Physician or word of mouth.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris D'Adamo, PhD | University of Maryland | Principal Investigator |
| Chris Mason, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | College Park | Maryland | 20742 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood, saliva, vaginal microbiome, stool microbiome
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |