Clinical trial · Observational
A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Women with PCOS
- description
- Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues
- interventionNames
- Other: No intervention study
- label
- Healthy controls
- description
- Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues
- interventionNames
- Other: No intervention study
Primary outcomes (4)
- measure
- Phenotype differences in vaginal microbiome
- timeFrame
- Samples to be collected on any day once per participant within 30 days of enrollment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available