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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
NA trial testing the group GS (probiotic) in Insulin Resistance in 40 participants. Completed in 20 July 2023.
1 February 2022
Quick facts
| Lead sponsor | Poznan University of Physical Education |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 April 2021 |
| Primary completion | 1 February 2022 |
| Estimated completion | 20 July 2023 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- the group GS (probiotic)
- the group GP (placebo)
Conditions studied
- Insulin Resistance — all drugs for Insulin Resistance →
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):
-
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:
- PubMed search for NCT06092060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Poznan University of Physical Education trials
Trials by the same sponsor.
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- NCT07232836 — Cytokines, Neuroplasticity Modulators, and Biomarkers in Spinal Canal Stenosis and Endoscopic Decompression · NA · not yet recruiting
- NCT06935058 — Effectiveness of Chocolate Milk in Recovery Among Highly Trained Kayakers: A Metabolic and Inflammatory Perspectives · NA · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06092060 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poznan University of Physical Education
- Last refreshed: 23 October 2023
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.
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