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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2017
CompletedFirst Submitted
Initial submission to the registry
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2018
CompletedOctober 30, 2017
October 1, 2017
1.3 years
October 20, 2017
October 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of body mass and body fat percentage
Assessed using the Tanita MC-980 Body Composition Analyzer
6 months
Secondary Outcomes (3)
Decrease of testosterone levels
6 months
Increased regularity of menstrual cycle
6 months
Improved homeostasis of the intestinal microflora
6 months
Study Arms (2)
Active Comparator:
ACTIVE COMPARATORDietary modification + Probiotic supplementation (Sanprobi Super Formula)
Placebo Comparator
PLACEBO COMPARATORDietary modification + placebo.
Interventions
Sanprobi Super Formula consisting of: Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus lactis, Fructooligosacharide, Inulin.
Eligibility Criteria
You may qualify if:
- Written consent for participation in the clinical trial
- Age 18 to 45 years Irregular menstruation (\> 35 days) or secondary amenorrhea\> 3 months
- \. Hyperandrogenism (hirsutism and / or acne) and / or hyperandrogenemia (total serum testosterone\> 0.5 ng / mL) 5. BMI \> 25
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poznan University of Medical Scienceslead
- University of California, San Diegocollaborator
- Sanprobicollaborator
Study Sites (1)
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan, 61701, Poland
Related Publications (2)
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.
PMID: 39636391DERIVEDChudzicka-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: 34050763DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD Associate Proffesor Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 30, 2017
Study Start
May 20, 2017
Primary Completion
September 20, 2018
Study Completion
October 20, 2018
Last Updated
October 30, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share