Actively Recruiting
Gut- and Vaginal Microbiome Composition in Association With PCOS
Led by Erasmus Medical Center · Updated on 2024-09-19
200
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gut- and Vaginal Microbiome Composition in Association With PCOS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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: clinical or biochemical hyperandrogenism (modified Ferriman-Gallwey score >5; testosterone level >2nmol/L, Free Androgen Index > 2.9), oligomenorrhea or amenorrhea, polycystic ovaries
You will not qualify if you...
- Body mass index (BMI) less than 18
- Smoking
- Diabetes Mellitus or use of insulin sensitizer
- Chronic and acute infectious diseases
- Endometriosis (American Fertility Score III/IV)
- Elevated prolactin levels, thyroid disease, Cushing disease, or gastrointestinal disease
- Use of hormonal contraceptives or other steroid hormones in the last 3 months
- Use of antibiotics, probiotics, or laxatives in the last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
X
Xu Shan Gao, drs.
CONTACT
S
Sam Schoenmakers, Dr. drs.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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