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

• Sponsor: Poznan University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03325023
• Collaborator: University of California, San Diego (Other), Sanprobi (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
PCOS	Dietary Supplement: Dietary and life style modification and probiotic Sanprobi Super Formula; Other: Placebo	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 20, 2017
• Anticipated Primary Completion Date: Sep 20, 2018
• Anticipated Study Completion Date: Oct 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Comparator: Dietary modification + Probiotic supplementation (Sanprobi Super Formula)	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.
Placebo Comparator: Placebo Comparator Dietary modification + placebo.	Other: Placebo; Placebo; Other Names: Dietary and life style modification and placebo

Outcome Measures

Primary Outcome Measures

1. Reduction of body mass and body fat percentage [6 months]

   Assessed using the Tanita MC-980 Body Composition Analyzer

Secondary Outcome Measures

1. Decrease of testosterone levels [6 months]

2. Increased regularity of menstrual cycle [6 months]

3. Improved homeostasis of the intestinal microflora [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics	Poznań		Poland	61701

Sponsors and Collaborators

• Poznan University of Medical Sciences
• University of California, San Diego
• Sanprobi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beata Banaszewska, MD PhD Associate Proffesor Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics, Poznan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03325023
• Other Study ID Numbers: PoznanUMS5
• First Posted: Oct 30, 2017
• Last Update Posted: Oct 30, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Beata Banaszewska, MD PhD Associate Proffesor Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics, Poznan University of Medical Sciences: PCOS, microbiota, probiotic,obesity
• Additional relevant MeSH terms: Polycystic Ovary Syndrome

Study Results

No Results Posted as of Oct 30, 2017