NCT06761625

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

Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake: A 12-week Placebo Controlled and Randomized Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Pomeranian Medical University Szczecin · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PCOS

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SanProbi® Barrier capsules	The probiotic group received SanProbi® Barrier capsules
OTHER	Placebo	The placebo group received capsules filled mainly with maize starch and maltodextrins.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2025-01-07
• Last updated: 2025-01-07

Locations

1 site across 1 country: Poland