✓ Translated by DotMD AI Clinical Council Source: Nutrients • Randomized Controlled Trial
Verify Primary Source: NIH PubMed PMID #41097174 ↗

Randomized Controlled Trial: Bifidobacterium animalis subsp. lactis TISTR 2591 Improves Glycemic Control and Immune Response in Adults with Type 2 Diabetes Mellitus

Original Paper Title: “Bifidobacterium animalis subsp. lactis TISTR 2591 Improves Glycemic Control and Immune Response in Adults with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Crossover Clinical Trial”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Randomized Controlled Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Conclusions : BA-2591 was safe and demonstrated modest, adjunctive benefits for fasting glycemia and immunologic profiles over 6 weeks, without changes in body weight or fat mass.
  • Study Design & Sample: Randomized Controlled Trial published in Nutrients (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Nutrients (2025), this randomized controlled trial evaluating human clinical outcomes investigated: Background/Objectives : Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder marked by insulin resistance, hyperglycemia, systemic inflammation, and immune imbalance. Key clinical takeaway: Conclusions : BA-2591 was safe and demonstrated modest, adjunctive benefits for fasting glycemia and immunologic profiles over 6 weeks, without changes in body weight or fat mass.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Nutrients, 2025-09-29; Randomized Controlled Trial; Rigor 88/100): Conclusions : BA-2591 was safe and demonstrated modest, adjunctive benefits for fasting glycemia and immunologic profiles over 6 weeks, without changes in body weight or fat mass.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Randomized Controlled Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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