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Completed

NCT Number: 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 were analised after probiotic intake.

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Key information

Conditions

PCOS

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pomeranian Medical University

Szczecin, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SanProbi® Barrier capsules

Dietary Supplement

The probiotic group received SanProbi® Barrier capsules

Placebo

Other

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

Primary outcomes

  1. Changes in hormonal profile after probiotics intake

    Time frame: 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 outcomes

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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