Clinical trial NCT03325023: Effect of Dietary Modifacation on Microbiota in Overweight and Obese Polycystic Ovary Syndrome Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PCOS
Keywords: PCOS, microbiota, probiotic,obesity
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Sanprobi
First posted: 2017-10-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Reduction of body mass and body fat percentage
timeFrame: 6 months
Secondary outcomes:
measure: Decrease of testosterone levels
timeFrame: 6 months
measure: Increased regularity of menstrual cycle
timeFrame: 6 months
measure: Improved homeostasis of the intestinal microflora
timeFrame: 6 months
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Study officials:
References:
citation: 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.