Clinical trial · Observational
Gut- and Vaginal Microbiome Composition in Association With PCOS
Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.
- 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)
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects up to 10% of the reproductive-aged women worldwide. The etiology is still unknown and treatment therefore remains symptomatic. Studies indicate a possible role of the gut microbiome in the pathology of PCOS. PCOS women have a disturbed gut microbiome, with certain species associated with the PCOS characteristics:hyperandrogenism, ovarian dysfunction, obesity, glucose intolerance and insulin resistance. Although differences have been found in gut microbiome composition between PCOS and healthy women, the literature is inconclusive regarding the difference in gut microbiome biodiversity. Studies examining the vaginal microbiome in PCOS women show consistent results with specific species in the vaginal microbiome. However, there are only few studies on the vaginal microbiome in PCOS women and no studies have yet investigated the correlation between sex-specific hormones and PCOS characteristics. More research is needed to understand the function of the microbiome in the pathophysiology of PCOS, so that this can offer perspectives in future therapies.
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 |
|---|---|---|---|
| Venous blood sample, vaginal swab | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Polycystic ovary syndrome (PCOS)
- description
- * Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire
- interventionNames
- Other: Venous blood sample, vaginal swab
- label
- Control group
- description
- * Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire
- interventionNames
- Other: Venous blood sample, vaginal swab
Primary outcomes (1)
- measure
- Bacterial composition of the gut in women with PCOS and control group
- timeFrame
- 1 week
- description
- Bacterial composition in the gut is analysed using 16S rRNA gene sequencing
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion criteria * Caucasian * Willing to provide vaginal swab and stool sample * Willing to provide informed consent * Sufficient command of the Dutch language * Diagnosed with PCOS at Erasmus MC using the Rotterdam criteria by the presence of at least two of the following criteria * Clinical or biochemical hyperandrogenism (modified Ferriman-Gallway score \>5; testosterone level \>2nmol/L, Free Androgen Index \> 2.9) * Oligomenorrorrhea or amenorrhea * Polycystic ovaries. Exclusion criteria * BMI \<18 * Smoking * Diabetes Mellitus or use of insulin sensitizer * Chronic and acute infection diseases * Endometriosis (American Fertility Score (AFS) III/IV) * Elevated prolactin levels, thyroid disease, Cushing disease or gastro-intestinal disease * The use of hormonal contraceptives, and other steroid hormones in the last 3 months * Use of antibiotics, probiotics or laxatives in the last 3 months
References
Publications (0)
Data not yet available