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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03325023
• Other study ID #: PoznanUMS5
• Status: Recruiting
• Phase: Phase 4
• First received: October 20, 2017
• Last updated: October 26, 2017
• Start date: May 20, 2017
• Est. completion date: October 20, 2018

Study information

• Verified date: October 2017
• Source: Poznan University of Medical Sciences
• Contact: Beata Banaszewska, MD PhD
• Phone: +48501303173
• Email: bbeata48[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Written consent for participation in the clinical trial

2. 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:

1. Ovarian cancer, adrenal gland tumor, endometrial cancer, cervical cancer, breast cancer

2. Congenital adrenal hyperplasia (17-OH-progesterone> 2.5 ng / mL)

3. Clinically diagnosed Cushing's disease, acromegaly, gigantism

4. Type I or II diabetes

5. Unexplained bleeding from the genital tract

6. Hormone treatment within the last 2 months

Related Conditions & MeSH terms

• PCOS
• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• Dietary and life style modification and probiotic Sanprobi Super Formula
Sanprobi Super Formula consisting of: Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus lactis, Fructooligosacharide, Inulin.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Poland	Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics	Poznan

Sponsors (3)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	Sanprobi, University of California, San Diego

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of body mass and body fat percentage	Assessed using the Tanita MC-980 Body Composition Analyzer	6 months
Secondary	Decrease of testosterone levels		6 months
Secondary	Increased regularity of menstrual cycle		6 months
Secondary	Improved homeostasis of the intestinal microflora		6 months