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

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

Study Overview

• Status: Completed
• Conditions: PCOS
• Intervention / Treatment: Dietary supplement: SanProbi® Barrier capsules; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Szczecin, Poland
    • Pomeranian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics Intake; The probiotic group received SanProbi® Barrier capsules	Dietary supplement: SanProbi® Barrier capsules; The probiotic group received SanProbi® Barrier capsules
Placebo Comparator: Placebo Intake; The placebo group received capsules filled mainly with maize starch and maltodextrins.	Other: Placebo; The placebo group received capsules filled mainly with maize starch and maltodextrins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	12 weeks
Changes in BMI in women with polycystic ovary syndrome after probiotic intake	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	12 weeks

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: PCOS; probiotics; BMI; hormones
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome
• Other Study ID Numbers: 1/12/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No