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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| Sanprobi | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: | Active Comparator | Dietary modification + Probiotic supplementation (Sanprobi Super Formula) |
|
| Placebo Comparator | Placebo Comparator | Dietary modification + placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary and life style modification and probiotic Sanprobi Super Formula | Dietary Supplement | Sanprobi Super Formula consisting of: Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus lactis, Fructooligosacharide, Inulin. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of body mass and body fat percentage | Assessed using the Tanita MC-980 Body Composition Analyzer | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of testosterone levels | 6 months | |
| Increased regularity of menstrual cycle | 6 months | |
| Improved homeostasis of the intestinal microflora |
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Inclusion Criteria:
4. Hyperandrogenism (hirsutism and / or acne) and / or hyperandrogenemia (total serum testosterone> 0.5 ng / mL) 5. BMI > 25
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beata Banaszewska, MD PhD | Contact | +48501303173 | bbeata48@gmail.com | |
| Anna Kubiak | Contact | +48500725005 | a.kubiak@vp.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics | Recruiting | Poznan | 61701 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39636391 | Derived | 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. | |
| 34050763 |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Placebo | Other | Placebo |
|
|
| 6 months |
| 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. |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |