Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake: A 12-week Placebo Controlled and Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in hormonal profile after probiotics intake
研究概览
简要总结
Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with PCOS, diagnosed based on Rotterdam ESHRE criteria
排除标准
- •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
结局指标
主要结局
Changes in hormonal profile after probiotics intake
时间窗: 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.
次要结局
- Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake(12 weeks)
- Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake(12 weeks)
- Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake(12 weeks)
- Changes in SHBG in women with polycystic ovary syndrome after probiotic intake(12 weeks)
- Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake(12 weeks)
- Changes in BMI in women with polycystic ovary syndrome after probiotic intake(12 weeks)
