Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake

Pomeranian Medical University Szczecin50 enrolled

Overview

Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.

50 women with PCOS , diagnosed based on Rotterdam ESHRE criteria,were assigned to two groups - the probiotics one and the placebo one. Women from the probiotics group were given SanProbi® Barrier capsules. They were taking probiotics for 12 weeks. The placebo group received identical-looking capsules filled mainly with maize starch and maltodextrins. The study concentrates on analysing specific hormones before and after the intervention (giving the probiotics or a placebo to the patients). The serum samples were obtained on days 3-5 (early follicular phase) of menstrual cycle. In the laboratory studies, the following hormones were measured before and after 12-week intervention: Testosterone, Androstenedione, 17-hydroxyprogesterone (17(OH)P); follicle stimulating hormone (FSH), luteinising hormone (LH); estradiol (E2), prolactin (PRL), thyroid stimulating hormone (TSH), thyroxine (T4) and sex hormone binding globulin (SHBG). The weight and height were measured before and after 12-week intervention. BMI was also calculated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

PCOS

Interventions

SanProbi® Barrier capsulesDIETARY_SUPPLEMENT

The probiotic group received SanProbi® Barrier capsules

PlaceboOTHER

The placebo group received capsules filled mainly with maize starch and maltodextrins.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

Inclusion Criteria: * women with PCOS, diagnosed based on Rotterdam ESHRE criteria Exclusion Criteria: * The patients with comorbidities such as diabetes mellitus type I and II, heart diseas-es, liver diseases, hypertension, hypothyroidism should be excluded from the study

Locations (1)

Pomeranian Medical University

Szczecin, Poland

Outcomes

Primary Outcomes

Changes in hormonal profile after probiotics intake

The hormones will be measured before and after 12-week intervention: the main outcome measure will be androstenedione, prolactin, 17-hydroxyprogesterone and testosterone levels measured in ng/ml.

Time frame: 12 weeks

Secondary Outcomes

Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake

LH and FSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in mIU/ml

Time frame: 12 weeks

Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake

Estradiol levels will be measured before and after 12 weeks of probiotics intake. They are measured in pg/ml

Time frame: 12 weeks

Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake

TSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in μIU/ml

Time frame: 12 weeks

Changes in SHBG in women with polycystic ovary syndrome after probiotic intake

SHBG levels will be measured before and after 12 weeks of probiotics intake. They are measured in nmol/l

Time frame: 12 weeks

Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake

DHEA-S levels will be measured before and after 12 weeks of probiotics intake. They are measured in μg/dl

Time frame: 12 weeks

Changes in BMI in women with polycystic ovary syndrome after probiotic intake

Data from ClinicalTrials.gov

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