Prospective, Randomized, Double - Blind, Placebo Controlled Trial of Dietary Modification in Conjunction With Probiotic Therapy on Clinical and Endocrinological Parameters as Well as Body Composition in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Reduction of body mass and body fat percentage
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. The pathogenesis of PCOS is not fully understood. The intestinal microbiota are believed to be associated with the development of insulin resistance and obesity, and therefore contributing to the development of PCOS. Incresed permeability of the intestinal mucosal barier and absorbtion of lipoproteinase (LPS) from G (-) bacteria promotes chronic inflammation and may lead to insulin resistance.
Approximately 50-60% of women suffering from PCOS are obese. It is known that lifestyle modification and body mass reduction improves endocrine parameters and restores ovulatory menstrual cycles in most patients. Currently, the use of probiotics and prebiotics is playing an increasingly important role in the treatment of obesity through the modulation of intestinal microflora.
The objectives of the study are based on the following assumptions:
- Insulin resistance and compensatory hyperinsulinemia are important aspects in the pathogenesis of PCOS and co-morbidity of cardiovascular disease.
- Aberrations in the intestinal microflora are associated with the development of obesity and insulin resistance.
- Dietary modification combined with probiotic supplementation improves endocrine and metabolic profiles in women with PCOS.
详细描述
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. The pathogenesis of PCOS is not fully understood. The intestinal microbiota are believed to be associated with the development of insulin resistance and obesity, and therefore contributing to the development of PCOS. Incresed permeability of the intestinal mucosal barier and absorbtion of lipoproteinase (LPS) from G (-) bacteria promotes chronic inflammation and may lead to insulin resistance.
The microbiome consists of a complex community of microorganisms that live in the digestive tract. Intestinal microflora is colonized by various microorganisms, with the largest groups consisting of the Firmicutes, Bacteroides, Actinobacteria and Proteobacteria. Intestinal microflora has a beneficial effect on the host by competing with pathogenic bacteria, protecting the inegrity of the intestinal mucosal barier and stimulating the immune system. Some human gut microorganisms are involved In fermenting dietary fiber into short-chain fatty acids (SCFAs), such as acetic acid and butyric acid, which are then absorbed by the host. The most beneficial species of microbiota are Lactobacillus and Bifidobacterium.
Approximately 50-60% of women suffering from PCOS are obese. It is known that lifestyle modification and body mass reduction improves endocrine parameters and restores ovulatory menstrual cycles in most patients. Currently, the use of probiotics and prebiotics is playing an increasingly important role in the treatment of obesity through the modulation of intestinal microflora.
The objectives of the study are based on the following assumptions:
- Insulin resistance and compensatory hyperinsulinemia are important aspects in the pathogenesis of PCOS and co-morbidity of cardiovascular disease.
- Aberrations in the intestinal microflora are associated with the development of obesity and insulin resistance.
- Dietary modification combined with probiotic supplementation improves endocrine and metabolic profiles in women with PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written consent for participation in the clinical trial
- •Age 18 to 45 years Irregular menstruation (> 35 days) or secondary amenorrhea> 3 months
- •Hyperandrogenism (hirsutism and / or acne) and / or hyperandrogenemia (total serum testosterone> 0.5 ng / mL)
排除标准
- •Ovarian cancer, adrenal gland tumor, endometrial cancer, cervical cancer, breast cancer
- •Congenital adrenal hyperplasia (17-OH-progesterone> 2.5 ng / mL)
- •Clinically diagnosed Cushing's disease, acromegaly, gigantism
- •Type I or II diabetes
- •Unexplained bleeding from the genital tract
- •Hormone treatment within the last 2 months
研究组 & 干预措施
Active Comparator:
Dietary modification + Probiotic supplementation (Sanprobi Super Formula)
干预措施: Dietary and life style modification and probiotic Sanprobi Super Formula (Dietary Supplement)
Placebo Comparator
Dietary modification + placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Reduction of body mass and body fat percentage
时间窗: 6 months
Assessed using the Tanita MC-980 Body Composition Analyzer
次要结局
- Decrease of testosterone levels(6 months)
- Increased regularity of menstrual cycle(6 months)
- Improved homeostasis of the intestinal microflora(6 months)
研究者
Beata Banaszewska
MD PhD Associate Proffesor Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan University of Medical Sciences