Multi‐Strain Probiotics BLa80 , LRa05 , and BBr60 Modulate Inflammation, Bile Acids, and Gut Microbiota in Type 2 Diabetes: A Randomized Controlled Trial

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Abstract
To evaluate the effects of a multi‐strain probiotic formula, Bifidobacterium animalis subsp. lactis BLa80, Lacticaseibacillus rhamnosus LRa05, and Bifidobacterium breve BBr60, on inflammation, metabolism, and the gut microbiota in patients with type 2 diabetes mellitus (T2DM). In a randomized, double‐blind, placebo‐controlled trial, 80 adults with T2DM received either the probiotic or a placebo in addition to standard hypoglycemic therapy for 12 weeks. We assessed inflammatory cytokines, glycemic indices, serum amino acids, bile acids (BAs), short‐chain fatty acids (SCFAs), and gut microbiota composition. Compared with the placebo group, the probiotic intervention led to a significant reduction in the levels of IL‐17 and TNF‐α ( p < 0.05 ), reduced serum concentrations of threonine, isoleucine, and arginine. Additionally, the BA profile was markedly altered, revealing 16 differential metabolites that were associated with pivotal metabolic pathways. SCFA analysis showed higher isobutyric and isovaleric acid after supplementation. The probiotic group also exhibited significant reductions in total glycated hemoglobin (GHb) and fasting plasma glucose (FPG, p < 0.05). Microbiome analyses indicated decreased alpha‐diversity and distinct beta‐diversity shifts, including increased Gemmatimonadota and reduced Clostridium abundance in the probiotic group. This multi‐strain probiotic modulated inflammatory responses, metabolic profiles, including BA metabolism and SCFAs, and gut microbiota composition in T2DM, supporting its potential as an adjunct to metabolic management. Trial Registration: ClinicalTrials.gov identifier: NCT06440486

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