Effect of Dietary Modifacation on Microbiota in Overweight and Obese Polycystic Ovary Syndrome Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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PCOS

Intervention / Treatment
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* Dietary Supplement: Dietary and life style modification and probiotic Sanprobi Super Formula
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent for participation in the clinical trial Age 18 to 45 years Irregular menstruation (> 35 days) or secondary amenorrhea> 3 months 4. Hyperandrogenism (hirsutism and / or acne) and / or hyperandrogenemia (total serum testosterone> 0.5 ng / mL) 5. BMI > 25 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator:<br>Dietary modification + Probiotic supplementation (Sanprobi Super Formula) | Dietary Supplement: Dietary and life style modification and probiotic Sanprobi Super Formula<br>* Sanprobi Super Formula consisting of: Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus lactis, Fructooligosacharide, Inulin.<br>|
| Placebo Comparator: Placebo Comparator<br>Dietary modification + placebo. | Other: Placebo<br>* Placebo<br>* Other names: Dietary and life style modification and placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of body mass and body fat percentage | Assessed using the Tanita MC-980 Body Composition Analyzer | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of testosterone levels |  | 6 months | 
| Increased regularity of menstrual cycle |  | 6 months | 
| Improved homeostasis of the intestinal microflora |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, microbiota, probiotic,obesity