PCOS
Conditions
Keywords
PCOS, probiotics, hormones, BMI
Brief summary
Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.
Detailed description
50 women with PCOS , diagnosed based on Rotterdam ESHRE criteria,were assigned to two groups - the probiotics one and the placebo one. Women from the probiotics group were given SanProbi® Barrier capsules. They were taking probiotics for 12 weeks. The placebo group received identical-looking capsules filled mainly with maize starch and maltodextrins. The study concentrates on analysing specific hormones before and after the intervention (giving the probiotics or a placebo to the patients). The serum samples were obtained on days 3-5 (early follicular phase) of menstrual cycle. In the laboratory studies, the following hormones were measured before and after 12-week intervention: Testosterone, Androstenedione, 17-hydroxyprogesterone (17(OH)P); follicle stimulating hormone (FSH), luteinising hormone (LH); estradiol (E2), prolactin (PRL), thyroid stimulating hormone (TSH), thyroxine (T4) and sex hormone binding globulin (SHBG). The weight and height were measured before and after 12-week intervention. BMI was also calculated.
Interventions
DIETARY_SUPPLEMENTSanProbi® Barrier capsules
The probiotic group received SanProbi® Barrier capsules
OTHERPlacebo
The placebo group received capsules filled mainly with maize starch and maltodextrins.
Sponsors
Pomeranian Medical University Szczecin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* women with PCOS, diagnosed based on Rotterdam ESHRE criteria
Exclusion criteria
* The patients with comorbidities such as diabetes mellitus type I and II, heart diseas-es, liver diseases, hypertension, hypothyroidism should be excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hormonal profile after probiotics intake | 12 weeks | The hormones will be measured before and after 12-week intervention: the main outcome measure will be androstenedione, prolactin, 17-hydroxyprogesterone and testosterone levels measured in ng/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake | 12 weeks | Estradiol levels will be measured before and after 12 weeks of probiotics intake. They are measured in pg/ml |
| Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake | 12 weeks | TSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in μIU/ml |
| Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake | 12 weeks | LH and FSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in mIU/ml |
| Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake | 12 weeks | DHEA-S levels will be measured before and after 12 weeks of probiotics intake. They are measured in μg/dl |
| Changes in BMI in women with polycystic ovary syndrome after probiotic intake | 12 weeks | BMI will be measured before and after 12 weeks of probiotics intake. Weight and height will be combined to report BMI in kg/m\^2 |
| Changes in SHBG in women with polycystic ovary syndrome after probiotic intake | 12 weeks | SHBG levels will be measured before and after 12 weeks of probiotics intake. They are measured in nmol/l |
Countries
Poland
Outcome results
None listed