posted on 2025-01-22, 05:16authored byEDCBioSynergy
Alkalihalobacillus clausii AO1125 is a Gram-positive, rod-shaped, motile, spore-forming bacterium with recognized probiotic potential and antimicrobial properties, making it valuable for gastrointestinal health applications. This strain represents a subclone of a strain of Bacillus clausii was isolated from a grass field in Denmark, and deposited in the ARS Public Collection with NRRL Number B-4131 on 6/13/1972 . This subclone was selected for inclusion in a clinical trial based on improved tolerance to the digestive system environment.. Identification was confirmed through morphological, cultural, and genomic techniques, including 16S rRNA analysis and whole-genome sequencing, to assess antimicrobial resistance and virulence factors. Phenotypic characterization involved disk diffusion tests for antimicrobial resistance, cytotoxicity assays on Vero cells, and hemolytic activity assessment on erythrocytes. A Phase I, double-blind, placebo-controlled clinical trial with 99 healthy volunteers was conducted, with participants randomized into an AO1125 group (n=50) or placebo group (n=49). The study revealed that A. clausii AO1125 is non-pathogenic, non-cytotoxic, and non-hemolytic. The most common adverse event reported was mild gastrointestinal gas, which decreased over time. These results support the safety profile of A. clausii AO1125 and its potential for development as a probiotic.
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