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

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ClinicalTrials.gov Identifier: NCT03325023
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
University of California, San Diego
Sanprobi
Information provided by (Responsible Party):
Beata Banaszewska, Poznan University of Medical Sciences

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : October 20, 2018

Resource links provided by the National Library of Medicine


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 Name: Dietary and life style modification and placebo




Primary Outcome Measures :
  1. Reduction of body mass and body fat percentage [ Time Frame: 6 months ]
    Assessed using the Tanita MC-980 Body Composition Analyzer


Secondary Outcome Measures :
  1. Decrease of testosterone levels [ Time Frame: 6 months ]
  2. Increased regularity of menstrual cycle [ Time Frame: 6 months ]
  3. Improved homeostasis of the intestinal microflora [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325023


Contacts
Contact: Beata Banaszewska, MD PhD +48501303173 bbeata48@gmail.com
Contact: Anna Kubiak +48500725005 a.kubiak@vp.pl

Locations
Poland
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics Recruiting
Poznań, Poland, 61701
Contact: Beata Banaszewska, MD PhD    +48501303173    bbeata48@gmail.com   
Contact: Anna Kubiak    +48500725005    a.kubiak@vp.pl   
Sub-Investigator: Antoni J Duleba, MD         
Sponsors and Collaborators
Poznan University of Medical Sciences
University of California, San Diego
Sanprobi

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     History of Changes
Other Study ID Numbers: PoznanUMS5
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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, Poznan University of Medical Sciences:
PCOS, microbiota, probiotic,obesity

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases