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Probiotic Intervention in PCOS

NCT04593459 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-03-22

No results posted yet for this study

Summary

The investigators are conducting a double-blinded randomized controlled trial to determine whether a probiotic mixture is effective in reducing PCOS-related symptoms. For this purpose, 180 participants will be recruited in three intervention arms (Probiotic, Placebo and Metformin), with 60 participants per arm. The intervention period will last 6 months, with extensive medical history, blood work, urine and stool analysis at the beginning and the conclusion of the trial.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DIETARY_SUPPLEMENT

Probiotic

See Arm description

DRUG

Metformin Hydrochloride

See Arm description

DIETARY_SUPPLEMENT

Probiotic Placebo

See Arm description

Sponsors & Collaborators

  • Institut AllergoSan

    collaborator UNKNOWN

  • Winclove Probiotics B.V.

    collaborator INDUSTRY

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Barbara Obermayer-Pietsch, Prof. MD · Medical University of Graz, Division of Endocrinology and Diabetology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2023-10-16
Completion
2023-10-16

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04593459 on ClinicalTrials.gov