Gut- and Vaginal Microbiome Composition in Association With PCOS

Polycystic Ovary Syndrome Clinical Trial

— GuVaPCOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706922
• Other study ID #: NL80648.078.22
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Xu Shan Gao, drs.
• Phone: +31631016348
• Email: x.gao[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Other:
• Venous blood sample, vaginal swab
Venous blood samples and vaginal swab will be obtained on the same day.

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam	South-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Difference in bacterial composition of the vagina and gut in women with PCOS	Relative abundance of bacterial communities	1 week
Secondary	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
Secondary	To analyse potential metabolic profiles characterizing different phenotypes of PCOS	Expression of metabolic indicators (metabolomics)	1 week