The main objectives of this study is to analyze differences in the gut and vaginal microbiome between healthy and PCOS women and investigate whether these differences correlate with PCOS characteristics. In addition, we want to look at a possible…
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in community structure of the gut microbiome between PCOS patients
and controls as such and its diagnostic and metabolic characteristics.
Secondary outcome
- Differences in community structure in the vaginal microbiome between PCOS
patients and controls as such and its diagnostic and metabolic
characteristics.
- Differences and similarities in community structure of the vaginal- and gut
microbiome in PCOS patients
- Differences and similarities between the vaginal- and gut microbiome
composition between overweight/obese and lean patients (with/without PCOS)
- To analyse potential metabolic profiles characterizing different phenotypes
of PCOS
Background 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 pathophysiologyof PCOS, so
that this can offer perspectives in future therapies.
Study objective
The main objectives of this study is to analyze differences in the gut and
vaginal microbiome between healthy and PCOS women and investigate whether these
differences correlate with PCOS characteristics. In addition, we want to look
at a possible correlation between the vaginal and gut microbiome in PCOS
patients. Finally, we will look at differences in microbiome composition
between obese and non-obese PCOS women.
Study design
Case control study
Study burden and risks
Patients diagnosed with PCOS using the COLA screening (abbreviation for Cycle
Disorder, Oligomenorrhoea and Amenorrhoea) and who agree to participate in the
GuVA study, will receive the PIF at the appointment of the COLA screening
result. The COLA screening is part of the regular care at the Reproductive
Medicine outpatient clinic, which means that in addition to completing a
questionnaire and physical examination, a gynecological ultrasound is also
performed. These data will be used for the GuVa study in agreement with the
patient. When the patient agrees to participate, she will receive instructions
to collect a portion of feces and bring it on the day of the second
appointment.
On the second appointment, a vaginal swab is taken (without speculum) by the
researcher. On the same day, additional blood parameters will be obtained for
the GuVa study. Finally, patients are asked to complete a food frequency
questionnaire online.
Doctor Molewaterplein 40 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Age 18-45years (premenopausal)
- 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 a presence
of at least two of the following criteria
o Clinical or biochemical hyperandrogenism (modified Ferriman-Gallway score >5;
testosterone level >2nmol/L, Free Androgen Index > 2.9)
o Oligomenorrorrhea or amenorrhea
o Polycystic ovaries.
Control group:
o Age 18-45years
o Caucasian
o Willing to provide vaginal and stool sample
o Willing to provide informed consent
o Regular menstrual cycle (25-35days)
o Sufficient command of the Dutch language
o No history of diagnosed PCOS and do not meet any of the Rotterdam criteria.
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, other steroid hormones in last 3 months
- Use of antibiotics, probiotics or laxatives in the last 3 months
The exclusion criteria also applies to the control group
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL80648.078.22 |