Abstract：
The human gut microbiome plays a crucial role in immune function. The synbiotic consortium or Defined Microbial Assemblage™ (DMA™) Medical Food product, SBD121, consisting of probiotic microbes and prebiotic fibers was designed for the clinical dietary management of rheumatoid arthritis. A 28-day repeated administration study was performed to evaluate the oral toxicity of SBD121 in male and female rats (age/weight at study start: 60 days/ 156-264 grams) administered levels of 0, 4.96 x 1010, 2.48 x 1011, or 4.96 x 1011 colony forming units (CFU)/kg-bw. No treatment related changes in ophthalmological effects, mortality, morbidity, general health and clinical observations, urinalysis, hematology, serum chemistry, absolute or relative organ weights, gross necropsy, or histopathology. A significant decrease in body weight was reported in females in the low and high-concentration groups, which corresponded in part with a significant decrease in food consumption. Results of the functional observation battery indicated front grip strength was significantly greater in the high-concentration males compared to the controls; however, this effect was not considered adverse. Based on these findings, the administration of the Medical Food SBD121 to male and female rats has a no-observable adverse effect level (NOAEL) at the highest level tested of 4.96 x 1011 CFU/kg-bw.
摘要：
人体肠道微生物组在免疫功能中起着至关重要的作用。合生元联盟或定义的微生物组装™（DMA™）医疗食品，由益生菌微生物和益生元纤维组成的SBD121被设计用于类风湿性关节炎的临床饮食管理。进行28天重复给药研究以评估SBD121在雄性和雌性大鼠(研究开始时的年龄/体重:60天/156-264克)中的口服毒性,所述大鼠施用水平为0、4.96×1010、2.48×1011或4.96×1011集落形成单位(CFU)/kg-bw。没有治疗相关的眼科效果变化，死亡率,发病率，一般健康和临床观察，尿液分析,血液学,血清化学,绝对或相对器官重量，肉眼尸检,或组织病理学。据报道，低浓度和高浓度组的女性体重显着下降，这在一定程度上与食物消费的显著减少相对应。功能观察电池的结果表明，与对照组相比，高浓度男性的前握力明显更大；然而，这种效应不被认为是不利的.基于这些发现,在测试的最高水平为4.96x1011CFU/kg-bw时，对雄性和雌性大鼠施用医疗食品SBD121具有未观察到的不良反应水平（NOAEL）。
