BIO-CAT Microbials LLC, Shakopee, MN 55379, USA.
Toxicology Regulatory Services, Charlottesville, VA 22911, USA.
Nutrients. 2021 Feb 25;13(3):733. doi: 10.3390/nu13030733.
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. 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 × 10 CFU/kg bw/day). In a 28 day human tolerability trial, 10 × 10 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, MB40 does not pose any human health concerns under the conditions tested.
随着益生菌在膳食补充剂、食品和饮料中的日益普及，不仅要证实独特菌株的健康益处和功效，还要证实其安全性。为了消费者的安全和产品的透明度，菌株鉴定应包括全基因组测序，安全性评估应包括基因型和表型研究。MB40 是一种独特的菌株，用于膳食补充剂、食品和饮料，对其进行了安全性和耐受性的体外、体内和体内研究评估。评估了 MB40 中是否存在编码毒素和移动抗生素耐药性的不良遗传元件。在大鼠和健康志愿者中均评估了耐受性。体外和体外测试证实了不存在对人类安全有影响的肠毒素和移动抗生素耐药基因。在大鼠中，连续口服 14 天，MB40 的无明显不良反应水平（NOAEL）为 2000mg/kg bw/天（相当于 3.7×10 CFU/kg bw/天）。在为期 28 天的人类耐受性试验中，每天 10×10 CFU 的 MB40 耐受性良好。基于基因组测序、菌株特征、不良属性筛查以及在大鼠和人类中进行的适当设计的安全性评估研究的安全性证据，在测试条件下，MB40 不会对人类健康造成任何关注。
