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

P

Pomeranian Medical University Szczecin

Status

Completed

Conditions

PCOS

Treatments

Other: Placebo
Dietary Supplement: SanProbi® Barrier capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT06761625
1/12/2024

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups, including a placebo group

Probiotics Intake
Experimental group
Description:
The probiotic group received SanProbi® Barrier capsules
Treatment:
Dietary Supplement: SanProbi® Barrier capsules
Placebo Intake
Placebo Comparator group
Description:
The placebo group received capsules filled mainly with maize starch and maltodextrins.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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