Safety assessment of Lactobacillus brevis KB290 as a probiotic strain.
Lactobacillus brevis KB290 (KB290), a plant-derived probiotic lactic acid bacterium, reportedly improves gut health and stimulates immune function. Here we extensively investigated the geno-, acute, subacute, and subchronic toxicity of KB290 and its bacterial translocation potential. KB290 was non-mutagenic in the bacterial reverse mutation assay by the preincubation method. In the single oral dose toxicity test, KB290 at 10(9) cfu/ml was nontoxic at maximum capacity (20 ml/kg). When 10(8), 10(9), or 10(10) cfu/kg was administered daily to rats by gavage for 2 weeks (subacute assay), we observed no clear treatment-related effect and no evidence of bacterial translocation from the gastrointestinal tract. When it was administered for 13 weeks (subchronic assay), we again observed no clear treatment-related effect and no significant toxicological effect. Based on those results, we consider 10(10) cfu/kg per day, the highest dose tested, to be the no observed adverse effect level (NOAEL). These results suggest that KB290 is safe for human consumption.
Yakabe
T
T
Research Institute, Kagome Co, Ltd, Tochigi, Japan. Takafumi_Yakabe@kagome.co.jp
Moore
E L
EL
Yokota
S
S
Sui
H
H
Nobuta
Y
Y
Fukao
M
M
Palmer
H
H
Yajima
N
N
D000284:Administration, Oral; D000818:Animals; D018988:Bacterial Translocation / Q000187:drug effects; D001774:Blood Chemical Analysis; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects / Q000382:microbiology; D006801:Humans; D052196:Levilactobacillus brevis / Q000502:physiology*; D008136:Longevity / Q000187:drug effects; D008297:Male; D009154:Mutation / Q000187:drug effects; D019936:Probiotics / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D018675:Toxicity Tests / Q000379:methods*; D015430:Weight Gain / Q000187:drug effects