Gut- and Vaginal Microbiome Composition in Association With PCOS

Study Overview
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Brief Summary
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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.

Official Title
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Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Venous blood sample, vaginal swab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polycystic ovary syndrome (PCOS)<br>Hormonal screening Vaginal swab Fecal sample Blood samples Food Frequency Questionnaire | Other: Venous blood sample, vaginal swab<br>* Venous blood samples and vaginal swab will be obtained on the same day.<br>|
| Control group<br>Hormonal screening Vaginal swab Fecal sample Blood samples Food Frequency Questionnaire | Other: Venous blood sample, vaginal swab<br>* Venous blood samples and vaginal swab will be obtained on the same day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial composition of the gut in women with PCOS and control group | Bacterial composition in the gut is analysed using 16S rRNA gene sequencing | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial composition of the vagina in women with PCOS and control group | Bacterial composition in the vagina is analysed using 16S rRNA gene sequencing | 1 week | 
| Difference in bacterial composition of the vagina and gut in women with PCOS | Relative abundance of bacterial communities | 1 week | 
| Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS) | Relative abundance of bacterial communities | 1 week | 
| To analyse potential metabolic profiles characterizing different phenotypes of PCOS | Expression of metabolic indicators (metabolomics) | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiome, vaginal microbiome, polycystic ovary syndrome