NCT06761625

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
Last Updated

January 7, 2025

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

December 19, 2024

Last Update Submit

January 6, 2025

Conditions

PCOS

Keywords

PCOSprobioticshormonesBMI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    12 weeks

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

    12 weeks

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

    12 weeks

  • Changes in SHBG in women with polycystic ovary syndrome after probiotic intake

    12 weeks

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

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Probiotics Intake

EXPERIMENTAL

The probiotic group received SanProbi® Barrier capsules

Dietary Supplement: SanProbi® Barrier capsules

Placebo Intake

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

SanProbi® Barrier capsulesDIETARY_SUPPLEMENT

The probiotic group received SanProbi® Barrier capsules

Probiotics Intake
PlaceboOTHER

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

Placebo Intake

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PCOS, diagnosed based on Rotterdam ESHRE criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pomeranian Medical University

Szczecin, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 7, 2025

Study Start

December 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 7, 2025

Record last verified: 2024-12

Locations

PL(1)