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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Netherlands
Erasmus University Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Xu Shan Gao, drs.
x.gao@erasmusmc.nl
+31631016348
Backup
Sam Schoenmakers, Dr. drs.
s.schoenmakers@erasmusmc.nl
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2024-12
Participants
Target number of participants: 200
Treatments
Polycystic ovary syndrome (PCOS)
* Hormonal screening~* Vaginal swab~* Fecal sample~* Blood samples~* Food Frequency Questionnaire
Control group
* Hormonal screening~* Vaginal swab~* Fecal sample~* Blood samples~* Food Frequency Questionnaire
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov