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Recruiting NCT05706922

Gut- and Vaginal Microbiome Composition in Association With PCOS

Conditions: Polycystic Ovary Syndrome

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Enrollment: 200
Sponsor: Erasmus Medical Center

Location: Netherlands

Summary

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.

Eligibility Criteria

Inclusion criteriaCaucasianWilling to provide vaginal swab and stool sampleWilling to provide informed consentSufficient command of the Dutch languageDiagnosed with PCOS at Erasmus MC using the Rotterdam criteria by the presence of at least two of the following criteriaClinical or biochemical hyperandrogenism (modified Ferriman-Gallway score >5; testosterone level >2nmol/L, Free Androgen Index > 2.9)Oligomenorrorrhea or amenorrheaPolycystic ovaries.Exclusion criteriaBMI <18SmokingDiabetes Mellitus or use of insulin sensitizerChronic and acute infection diseasesEndometriosis (American Fertility Score (AFS) III/IV)Elevated prolactin levels, thyroid disease, Cushing disease or gastro-intestinal diseaseThe use of hormonal contraceptives, and other steroid hormones in the last 3 monthsUse of antibiotics, probiotics or laxatives in the last 3 months

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05706922). StuddyBuddy aggregates publicly available trial information.