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Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics Intake | Experimental | The probiotic group received SanProbi® Barrier capsules |
|
| Placebo Intake | Placebo Comparator | The placebo group received capsules filled mainly with maize starch and maltodextrins. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SanProbi® Barrier capsules | Dietary Supplement | The probiotic group received SanProbi® Barrier capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hormonal profile after probiotics intake | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake | LH and FSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in mIU/ml | 12 weeks |
| Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pomeranian Medical University | Szczecin | Poland |
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| Placebo | Other | The placebo group received capsules filled mainly with maize starch and maltodextrins. |
|
Estradiol levels will be measured before and after 12 weeks of probiotics intake. They are measured in pg/ml |
| 12 weeks |
| Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake | TSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in μIU/ml | 12 weeks |
| Changes in SHBG in women with polycystic ovary syndrome after probiotic intake | SHBG levels will be measured before and after 12 weeks of probiotics intake. They are measured in nmol/l | 12 weeks |
| Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake | DHEA-S levels will be measured before and after 12 weeks of probiotics intake. They are measured in μg/dl | 12 weeks |
| Changes in BMI in women with polycystic ovary syndrome after probiotic intake | 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 | 12 weeks |