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GuVaPCOS: Gut- and Vaginal Microbiome Composition in Association With PCOS

Sponsor
Erasmus Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05706922
Collaborator
(none)
200
Enrollment
1
Location
17.2
Anticipated Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Venous blood sample, vaginal swab

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.
Anticipated Study Start Date :
Jan 24, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Polycystic ovary syndrome (PCOS)

Hormonal screening Vaginal swab Fecal sample Blood samples Food Frequency Questionnaire

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

Hormonal screening Vaginal swab Fecal sample Blood samples Food Frequency Questionnaire

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Difference in bacterial composition of the vagina and gut in women with PCOS [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) [1 week]

    Relative abundance of bacterial communities

  4. To analyse potential metabolic profiles characterizing different phenotypes of PCOS [1 week]

    Expression of metabolic indicators (metabolomics)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erasmus University Medical Center Rotterdam South-Holland Netherlands 3015GD

Sponsors and Collaborators

  • Erasmus Medical Center

Investigators

  • Principal Investigator: Sam Schoenmakers, Dr. drs., Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology
  • Study Director: Joop S.E. Laven, Prof. dr., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Sam Schoenmakers, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT05706922
Other Study ID Numbers:
  • NL80648.078.22
First Posted:
Jan 31, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sam Schoenmakers, Principal Investigator, Erasmus Medical Center
gut microbiome
vaginal microbiome
polycystic ovary syndrome
Additional relevant MeSH terms:
Polycystic Ovary Syndrome

Study Results

No Results Posted as of Jan 31, 2023