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临床试验/NCT06761625
NCT06761625已完成不适用

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

Pomeranian Medical University Szczecin1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月1日最近更新:
适应症

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

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)

研究者

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Sponsor

研究点 (1)

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