Assessing the Safety and Probiotic Potential of Bifidobacterium longum subsp. infantis BI45: A Comprehensive Study from Genomic Analysis to Randomized Controlled Clinical Trial in Healthy Adults.
Probiotics Antimicrob ProteinsMay 12, 2026 (epub)
Shuai Song, LiMin Ding, SongTai Yang et al.
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In 30 seconds
This randomized controlled trial assessed the safety and efficacy of Bifidobacterium longum subsp. infantis BI45 in 48 healthy adults. The study found no adverse events or significant changes in health markers, indicating an excellent safety profile. Notably, supplementation with B. infantis BI45 significantly increased serum Immunoglobulin A (IgA) and antimicrobial peptide LL-37 levels compared to placebo (p < 0.05).
Key findings
- No transferable antibiotic resistance or virulence genes were identified in B. infantis BI45.
- The clinical trial showed no adverse events in the B. infantis BI45 group.
- Supplementation significantly increased serum IgA and LL-37 levels compared to placebo (p < 0.05).
- B. infantis BI45 modulated gut microbiota by enriching beneficial short-chain fatty acid producers.
Why it matters
Understanding the safety and efficacy of novel probiotic strains is crucial for clinicians considering their use in promoting gut health and immune function. This study provides robust evidence supporting the safety of B. infantis BI45.