Journal
NUTRIENTS
Volume 13, Issue 3, Pages -Publisher
MDPI
DOI: 10.3390/nu13030733
Keywords
Bacillus subtilis MB40; probiotics; safety; tolerability
Categories
Funding
- BIO-CAT Microbials, LLC
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The safety and tolerability of the unique strain Bacillus subtilis MB40 was assessed through in silico, in vitro, and in vivo studies. The study confirmed the absence of undesirable genetic elements encoding toxins and antibiotic resistance, and found that MB40 was well tolerated in both rats and healthy human volunteers. Based on the research, it was concluded that Bacillus subtilis MB40 does not pose any human health concerns under the tested conditions.
With the growing popularity of probiotics in dietary supplements, foods, and beverages, it is important to substantiate not only the health benefits and efficacy of unique strains but also safety. In the interest of consumer safety and product transparency, strain identification should include whole-genome sequencing and safety assessment should include genotypic and phenotypic studies. Bacillus subtilis MB40, a unique strain marketed for use in dietary supplements, and food and beverage, was assessed for safety and tolerability across in silico, in vitro, and in vivo studies. MB40 was assessed for the absence of undesirable genetic elements encoding toxins and mobile antibiotic resistance. Tolerability was assessed in both rats and healthy human volunteers. In silico and in vitro testing confirmed the absence of enterotoxin and mobile antibiotic resistance genes of safety concern to humans. In rats, the no-observed-adverse-effect level (NOAEL) for MB40 after repeated oral administration for 14 days was determined to be 2000 mg/kg bw/day (equivalent to 3.7 x 10(11) CFU/kg bw/day). In a 28 day human tolerability trial, 10 x 10(9) CFU/day of MB40 was well tolerated. Based on genome sequencing, strain characterization, screening for undesirable attributes and evidence of safety by appropriately designed safety evaluation studies in rats and humans, Bacillus subtilis MB40 does not pose any human health concerns under the conditions tested.
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