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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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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

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotics Intake

The probiotic group received SanProbi® Barrier capsules

Group Type EXPERIMENTAL

SanProbi® Barrier capsules

Intervention Type DIETARY_SUPPLEMENT

The probiotic group received SanProbi® Barrier capsules

Placebo Intake

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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SanProbi® Barrier capsules

The probiotic group received SanProbi® Barrier capsules

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No