Gut- and Vaginal Microbiome Composition in Association With PCOS

Last updated: September 12, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

Venous blood sample, vaginal swab

Clinical Study ID

NCT05706922
NL80648.078.22
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Venous blood sample, vaginal swab
Phase:
Study Start date:
November 16, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Erasmus University Medical Center

    Rotterdam, South-Holland 3015GD
    Netherlands

    Active - Recruiting

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