Clinical trial · Interventional
Effect of Dietary Modifacation on Microbiota in Overweight and Obese Polycystic Ovary Syndrome Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary and life style modification and probiotic Sanprobi Super Formula | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator:
- description
- Dietary modification + Probiotic supplementation (Sanprobi Super Formula)
- interventionNames
- Dietary Supplement: Dietary and life style modification and probiotic Sanprobi Super Formula
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator
- description
- Dietary modification + placebo.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Reduction of body mass and body fat percentage
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDChudzicka-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. PMID 39636391
- DERIVEDChudzicka-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. PMID 34050763