Mukerji Pushkor, Roper Jason M, Stahl Buffy, Smith Amy B, Burns Frank, Rae Jessica Caverly, Yeung Nicolas, Lyra Anna, Svärd Laura, Saarinen Markku T, Alhoniemi Esa, Ibarra Alvin, Ouwehand Arthur C
DuPont Stine-Haskell, Newark, DE, USA.
DuPont Stine-Haskell, Newark, DE, USA.
Food Chem Toxicol. 2016 Jun;92:117-28. doi: 10.1016/j.fct.2016.03.018. Epub 2016 Mar 23.
AB-LIFE(®) is a probiotic product consisting of equal parts of three strains of Lactobacillus plantarum (CECT 7527, 7528, and 7529) blended with inert excipients. Whole genome sequencing was performed on each of the three strains. Antibiotic resistance was evaluated by genomic mining for resistance genes, and assessment for transferability. No risk of transfer potential was identified for any antibiotic resistance genes in the three strains. AB-LIFE(®) was evaluated for potential subchronic oral toxicity in rats, with dosages of 300 and 1000 mg/kg BW/day (equivalent to 5.55 × 10(10) and 1.85 × 10(11) CFU/kg BW/day). Survival of the three test strains through the gastrointestinal tract was supported by fecal analysis. No adverse effects were identified with respect to in-life parameters, clinical or anatomic pathology, translocation, or fecal chemical analyses. The no-observed-adverse-effect level (NOAEL) for AB-LIFE(®) in male and female rats was 1000 mg/kg BW/day (1.85 × 10(11) CFU of AB-LIFE(®)/kg BW/day), the highest dose level evaluated. These results, in conjunction with a previous acute toxicity study in rats, support the conclusion that AB-LIFE(®) is safe for human consumption.
AB-LIFE(®)是一种益生菌产品，由等量的三株植物乳杆菌（CECT 7527、7528和7529）与惰性赋形剂混合而成。对这三株菌分别进行了全基因组测序。通过对耐药基因的基因组挖掘和转移能力评估来评价抗生素耐药性。在这三株菌中未发现任何抗生素耐药基因有转移潜力的风险。对AB-LIFE(®)进行了大鼠潜在亚慢性经口毒性评价，剂量为300和1000 mg/kg体重/天（相当于5.55×10¹⁰和1.85×10¹¹ CFU/kg体重/天）。粪便分析证实了这三株测试菌株在胃肠道中的存活情况。在活体参数、临床或解剖病理学、移位或粪便化学分析方面未发现不良反应。AB-LIFE(®)在雄性和雌性大鼠中的未观察到不良反应水平（NOAEL）为1000 mg/kg体重/天（1.85×10¹¹ CFU AB-LIFE(®)/kg体重/天），即所评估的最高剂量水平。这些结果与之前对大鼠的急性毒性研究相结合，支持AB-LIFE(®)供人类食用是安全的这一结论。
