Skip to content

Gut- and Vaginal Microbiome Composition in Association With PCOS

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05706922
Acronym
GuVaPCOS
Enrollment
200
Registered
2023-01-31
Start date
2023-11-16
Completion date
2024-12-31
Last updated
2024-09-19

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

Conditions

Polycystic Ovary Syndrome

Keywords

gut microbiome, vaginal microbiome, polycystic ovary syndrome

Brief 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.

Interventions

OTHERVenous blood sample, vaginal swab

Venous blood samples and vaginal swab will be obtained on the same day.

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bacterial composition of the gut in women with PCOS and control group1 weekBacterial composition in the gut is analysed using 16S rRNA gene sequencing

Secondary

MeasureTime frameDescription
To analyse potential metabolic profiles characterizing different phenotypes of PCOS1 weekExpression of metabolic indicators (metabolomics)
Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)1 weekRelative abundance of bacterial communities
Bacterial composition of the vagina in women with PCOS and control group1 weekBacterial composition in the vagina is analysed using 16S rRNA gene sequencing
Difference in bacterial composition of the vagina and gut in women with PCOS1 weekRelative abundance of bacterial communities

Countries

Netherlands

Contacts

Primary ContactXu Shan Gao, drs.
x.gao@erasmusmc.nl+31631016348
Backup ContactSam Schoenmakers, Dr. drs.
s.schoenmakers@erasmusmc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026