Examining the gut and vaginal microbiome in women with PCOS
Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.
This study looks at the gut and vaginal bacteria in women with PCOS to see how these bacteria might relate to their symptoms and health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05706922 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the composition of the gut and vaginal microbiomes in women diagnosed with Polycystic Ovary Syndrome (PCOS). It aims to explore the relationship between microbiome diversity and various PCOS characteristics, such as hyperandrogenism and insulin resistance. Participants will provide venous blood samples, vaginal swabs, and stool samples to analyze the microbiome's role in PCOS pathology. The study seeks to clarify the inconclusive findings in existing literature regarding microbiome differences between PCOS patients and healthy women.
Who should consider this trial
Good fit: Ideal candidates are Caucasian women diagnosed with PCOS who can provide informed consent and samples.
Not a fit: Patients with a BMI under 18, those who smoke, or have other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of PCOS and potentially inform new treatment strategies targeting the microbiome.
How similar studies have performed: While some studies have indicated a link between the gut microbiome and PCOS, this specific investigation into the vaginal microbiome and its correlation with hormonal characteristics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rotterdam, South Holland
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Sam Schoenmakers, Dr. drs. — Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology
- Study coordinator: Xu Shan Gao, drs.
- Email: x.gao@erasmusmc.nl
- Phone: +31631016348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.