Gut- and Vaginal Microbiome Composition in Association With PCOS

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Venous blood sample, vaginal swab

• Registration Number: NCT05706922
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-31
• Study Start: 2023-11-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Polycystic ovary syndrome (PCOS)	Venous blood sample, vaginal swab	* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire
Control group	Venous blood sample, vaginal swab	* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire

Primary Outcome Measures

Name	Time	Method
Bacterial composition of the gut in women with PCOS and control group	1 week	Bacterial composition in the gut is analysed using 16S rRNA gene sequencing

Secondary Outcome Measures

Name	Time	Method
To analyse potential metabolic profiles characterizing different phenotypes of PCOS	1 week	Expression of metabolic indicators (metabolomics)
Bacterial composition of the vagina in women with PCOS and control group	1 week	Bacterial composition in the vagina is analysed using 16S rRNA gene sequencing
Difference in bacterial composition of the vagina and gut in women with PCOS	1 week	Relative abundance of bacterial communities
Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)	1 week	Relative abundance of bacterial communities

Trial Locations

Locations (1)

Erasmus University Medical Center; 🇳🇱 Rotterdam, South-Holland, Netherlands