PCOS Clinical Trial
Official title:
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
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:
1. Insulin resistance and compensatory hyperinsulinemia are important aspects in the
pathogenesis of PCOS and co-morbidity of cardiovascular disease.
2. Aberrations in the intestinal microflora are associated with the development of obesity
and insulin resistance.
3. Dietary modification combined with probiotic supplementation improves endocrine and
metabolic profiles in women with PCOS.
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:
1. Insulin resistance and compensatory hyperinsulinemia are important aspects in the
pathogenesis of PCOS and co-morbidity of cardiovascular disease.
2. Aberrations in the intestinal microflora are associated with the development of obesity
and insulin resistance.
3. Dietary modification combined with probiotic supplementation improves endocrine and
metabolic profiles in women with PCOS.
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