Effect of Dietary Modifacation on Microbiota in Overweight and Obese Polycystic Ovary Syndrome Patients
NCT ID: NCT03325023
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2017-05-20
2018-10-20
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Comparator:
Dietary modification + Probiotic supplementation (Sanprobi Super Formula)
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
Dietary modification + placebo.
Placebo
Placebo
Interventions
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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
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
40 Years
FEMALE
No
Sponsors
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University of California, San Diego
OTHER
Sanprobi
UNKNOWN
Poznan University of Medical Sciences
OTHER
Responsible Party
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Beata Banaszewska
MD PhD Associate Proffesor Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Locations
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Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan, , Poland
Countries
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Central Contacts
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Facility Contacts
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Beata Banaszewska, MD PhD
Role: primary
Anna Kubiak
Role: backup
References
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Chudzicka-Strugala I, Kubiak A, Banaszewska B, Wysocka E, Zwozdziak B, Siakowska M, Pawelczyk L, Duleba AJ. Six-month randomized, placebo controlled trial of synbiotic supplementation in women with polycystic ovary syndrome undergoing lifestyle modifications. Arch Gynecol Obstet. 2025 Feb;311(2):499-506. doi: 10.1007/s00404-024-07833-3. Epub 2024 Dec 5.
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.
Other Identifiers
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PoznanUMS5
Identifier Type: -
Identifier Source: org_study_id