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

Primary Purpose

PCOS

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Dietary and life style modification and probiotic Sanprobi Super Formula
Placebo
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring PCOS, microbiota, probiotic,obesity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Infertility and Reproductive Endocrinology, Department of Gynecology and ObstericsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Comparator:

Placebo Comparator

Arm Description

Dietary modification + Probiotic supplementation (Sanprobi Super Formula)

Dietary modification + placebo.

Outcomes

Primary Outcome Measures

Reduction of body mass and body fat percentage
Assessed using the Tanita MC-980 Body Composition Analyzer

Secondary Outcome Measures

Decrease of testosterone levels
Increased regularity of menstrual cycle
Improved homeostasis of the intestinal microflora

Full Information

First Posted
October 20, 2017
Last Updated
October 26, 2017
Sponsor
Poznan University of Medical Sciences
Collaborators
University of California, San Diego, Sanprobi
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1. Study Identification

Unique Protocol Identification Number
NCT03325023
Brief Title
Effect of Dietary Modifacation on Microbiota in Overweight and Obese Polycystic Ovary Syndrome Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Anticipated)
Study Completion Date
October 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences
Collaborators
University of California, San Diego, Sanprobi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
Keywords
PCOS, microbiota, probiotic,obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator:
Arm Type
Active Comparator
Arm Description
Dietary modification + Probiotic supplementation (Sanprobi Super Formula)
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Dietary modification + placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary and life style modification and probiotic Sanprobi Super Formula
Intervention Description
Sanprobi Super Formula consisting of: Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus lactis, Fructooligosacharide, Inulin.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dietary and life style modification and placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Reduction of body mass and body fat percentage
Description
Assessed using the Tanita MC-980 Body Composition Analyzer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Decrease of testosterone levels
Time Frame
6 months
Title
Increased regularity of menstrual cycle
Time Frame
6 months
Title
Improved homeostasis of the intestinal microflora
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beata Banaszewska, MD PhD
Phone
+48501303173
Email
bbeata48@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Kubiak
Phone
+48500725005
Email
a.kubiak@vp.pl
Facility Information:
Facility Name
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
City
Poznań
ZIP/Postal Code
61701
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beata Banaszewska, MD PhD
Phone
+48501303173
Email
bbeata48@gmail.com
First Name & Middle Initial & Last Name & Degree
Anna Kubiak
Phone
+48500725005
Email
a.kubiak@vp.pl
First Name & Middle Initial & Last Name & Degree
Antoni J Duleba, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34050763
Citation
Chudzicka-Strugala I, Kubiak A, Banaszewska B, Zwozdziak B, Siakowska M, Pawelczyk L, Duleba AJ. Effects of Synbiotic Supplementation and Lifestyle Modifications on Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2021 Aug 18;106(9):2566-2573. doi: 10.1210/clinem/dgab369.
Results Reference
derived

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

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