Changes in gut- and vaginal microbiome composition in association with PCOS clinical phenotypes
- Conditions
- polycystic ovary syndrome10014701
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
- Age 18-45years (premenopausal)
- 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 a presence
of at least two of the following criteria
o Clinical or biochemical hyperandrogenism (modified Ferriman-Gallway score >5;
testosterone level >2nmol/L, Free Androgen Index > 2.9)
o Oligomenorrorrhea or amenorrhea
o Polycystic ovaries.
Control group:
o Age 18-45years
o Caucasian
o Willing to provide vaginal and stool sample
o Willing to provide informed consent
o Regular menstrual cycle (25-35days)
o Sufficient command of the Dutch language
o No history of diagnosed PCOS and do not meet any of the Rotterdam 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, other steroid hormones in last 3 months
- Use of antibiotics, probiotics or laxatives in the last 3 months
The exclusion criteria also applies to the control group
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Differences in community structure of the gut microbiome between PCOS patients<br /><br>and controls as such and its diagnostic and metabolic characteristics. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Differences in community structure in the vaginal microbiome between PCOS<br /><br>patients and controls as such and its diagnostic and metabolic<br /><br>characteristics.<br /><br>- Differences and similarities in community structure of the vaginal- and gut<br /><br>microbiome in PCOS patients<br /><br>- Differences and similarities between the vaginal- and gut microbiome<br /><br>composition between overweight/obese and lean patients (with/without PCOS)<br /><br>- To analyse potential metabolic profiles characterizing different phenotypes<br /><br>of PCOS </p><br>