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Changes in gut- and vaginal microbiome composition in association with PCOS clinical phenotypes

Changes in gut- and vaginal microbiome composition in association with PCOS clinical phenotypes - GuVa PCOS study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51568
Enrollment
200
Registered
2022-10-11
Start date
2022-10-17
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - BMI

Design outcomes

Primary

MeasureTime frame
Differences in community structure of the gut microbiome between PCOS patients and controls as such and its diagnostic and metabolic characteristics.

Secondary

MeasureTime frame
- Differences in community structure in the vaginal microbiome between PCOS patients and controls as such and its diagnostic and metabolic characteristics. - Differences and similarities in community structure of the vaginal- and gut microbiome in PCOS patients - Differences and similarities between the vaginal- and gut microbiome composition between overweight/obese and lean patients (with/without PCOS) - To analyse potential metabolic profiles characterizing different phenotypes of PCOS

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)