Last reviewed · How we verify

NCT06092060

The Effect of a Multistrain Probiotic on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study

Completed NA Last updated 23 October 2023
What this trial tests

NA trial testing the group GS (probiotic) in Insulin Resistance in 40 participants. Completed in 20 July 2023.

Timeline
1 April 2021
Primary endpoint
1 February 2022
20 July 2023

Quick facts

Lead sponsorPoznan University of Physical Education
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment40
Start date1 April 2021
Primary completion1 February 2022
Estimated completion20 July 2023
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Poznan University of Physical Education

Who can join

Adults 25 to 45, female only, with Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy. The hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects. Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a placebo (GP). The randomization scheme will be computer-generated using permuted blocks of block size 4.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Multi-strain probiotic reduces gastrointestinal side effects in women with elevated HOMA-IR index treated with metformin: a 12-week randomised controlled trial.
    Ratajczak M, Bilska A, Musialik K, Skonieczna-Żydecka K, et al · · 2026 · cited 1× · PMID 41852479 · DOI 10.3389/fendo.2026.1765741

Verify or expand the search:

Other recruiting trials for Insulin Resistance

Currently open trials in the same condition.

Other Poznan University of Physical Education trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06092060.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing