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NCT Number: NCT05706922

Gut- and Vaginal Microbiome Composition in Association With PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Erasmus University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location status: Recruiting

Location contact

Xu Shan Gao, Drs

CONTACT

[email protected]

+31631016348

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous blood sample, vaginal swab

Other

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

Primary outcomes

  1. Bacterial composition of the gut in women with PCOS and control group

    Time frame: 1 week

    Bacterial composition in the gut is analysed using 16S rRNA gene sequencing

Secondary outcomes

  1. Bacterial composition of the vagina in women with PCOS and control group

    Time frame: 1 week

    Bacterial composition in the vagina is analysed using 16S rRNA gene sequencing

  2. Difference in bacterial composition of the vagina and gut in women with PCOS

    Time frame: 1 week

    Relative abundance of bacterial communities

  3. Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)

    Time frame: 1 week

    Relative abundance of bacterial communities

  4. To analyse potential metabolic profiles characterizing different phenotypes of PCOS

    Time frame: 1 week

    Expression of metabolic indicators (metabolomics)

Study contacts

Contact information is provided by the study sponsor or research team.

Sam Schoenmakers, Dr. drs.

CONTACT

[email protected]

Xu Shan Gao, drs.

CONTACT

[email protected]

+31631016348

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: GuVaPCOS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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