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

Not Applicable

Completed

• Conditions: PCOS

• Registration Number: NCT06761625
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2019-12-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in hormonal profile after probiotics intake	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake	12 weeks	LH and FSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in mIU/ml
Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake	12 weeks	Estradiol levels will be measured before and after 12 weeks of probiotics intake. They are measured in pg/ml
Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake	12 weeks	TSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in μIU/ml
Changes in SHBG in women with polycystic ovary syndrome after probiotic intake	12 weeks	SHBG levels will be measured before and after 12 weeks of probiotics intake. They are measured in nmol/l
Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake	12 weeks	DHEA-S levels will be measured before and after 12 weeks of probiotics intake. They are measured in μg/dl
Changes in BMI in women with polycystic ovary syndrome after probiotic intake	12 weeks	BMI will be measured before and after 12 weeks of probiotics intake. Weight and height will be combined to report BMI in kg/m\^2

Trial Locations

Locations (1)

Pomeranian Medical University; 🇵🇱 Szczecin, Poland