COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores(DreamTec Research)

The pharmacokinetics of drugs significantly affects their efficacy and adverse effects. Clarifying and predicting individual pharmacokinetic differences is crucial for the appropriate use of pharmaceuticals. Recent studies have suggested that the metabolic potential of intestinal bacteria may influence individual differences in pharmacokinetics. The consumption of probiotics, including supplements and fermented foods, has increased as a recent health trend. However, probiotics may also influence drug pharmacokinetics. In this study, we focused on the immunosuppressive drugs tacrolimus, everolimus, and cyclosporin A, which require careful dosing regimens, and investigated their interactions with microorganisms present in probiotics. Among the evaluated microorganisms, Bacillus subtilis exhibited a particularly strong drug degradation activity, with B. subtilis TO-A reducing the residual rates of tacrolimus and everolimus by 8 and 17%, respectively, in vitro. In a nonclinical pharmacokinetic trial, mice administered B. subtilis TO-A showed a significant reduction in the maximum blood concentration of tacrolimus. The concentration was 86.36 ± 63.61 ng/mL, much lower than that (212.8 ± 67.40 ng/mL) observed in the non-administered group. Based on these results, we can infer that orally ingested microorganisms can metabolize pharmaceuticals before reaching the small intestine, which is the primary site of absorption. These findings strongly suggest the need for caution when concurrently administering tacrolimus and probiotics in humans.

The supplementation of direct-fed microbials (DFMs), specifically Bacillus subtilis, can enhance nutrient digestibility and intestinal health, particularly under low-protein dietary conditions. This study assessed the effects of B. subtilis on broiler chickens through a controlled experiment involving 96 broilers randomly allocated to two groups: one fed a low-protein diet (13.5 % crude protein) alone, and the other supplemented with B. subtilis (1.0 × 10⁹ CFU/mL daily) in same diet. Growth performance, intestinal histology, digestive enzyme activity, and gut microbial high-throughput sequencing (HTS) techniques were evaluated. By day 42, supplemented birds weighed 2176 ± 45 g versus 2,023 ± 51 g in controls (+7.6 %, P = 0.003) while consuming 5.2 % less feed, reducing FCR from 1.71 to 1.55. Enhanced intestinal morphology was evidenced by increased villus height and villus-to-crypt ratio. B. subtilis supplementation also increased α-amylase activity while modulating gut microbiota composition, notably by elevating Firmicutes and Butyricicoccus abundance and reducing Bacteroidetes, Bacteroides, and Faecalibacterium. Hence, these findings underscore the potential of B. subtilis as a dietary supplement to improve poultry performance and gut health under protein-restricted conditions.