Safety assessment of probiotic Lactobacillus fermentum MTCC-5898 (LF) with three doses (10⁷, 10⁹, and 10¹¹ cfu/day/animal) was carried on Swiss albino mouse weanlings for 28 days using oral route. Health status of animals was monitored by physical assessment of body weight, organ indices, and histological appearances of liver and intestine along with measurement of hematological parameters (Hb, WBC, RBC count, MCHC, MCV, MCH), biochemical analytes in blood involving glucose, serum enzymes (ALT, AST and LDH), urea, creatinine, and lipid profile (total cholesterol, triglycerides, HDL, VLDL, LDL, and atherogenic index). LF showed no adverse effects on above parameters of general health status after continuous consumption for the experimental period. On the other hand, significant increase (p ≤ 0.05) in TGF-β (regulatory cytokine) and considerable decrease (p ≤ 0.05) in IFN-γ (pro-inflammatory cytokine) without any major changes in IL-4 and IL-12 in intestinal fluid on consumption of 10⁹ cfu/animal/day confirmed its dose-specific response for immune homeostasis. Further, safety of LF was also confirmed by insignificant changes in release of FITC-dextran (4 kDa) in blood on its consumption than control group where only saline was given orally. Moreover, significantly (p ≤ 0.05) increased mRNA expression of claudin-1 and MUC-2 in intestinal epithelial cells on feeding L. fermentum further supported FITC-dextran permeability data which otherwise showed increased flux of FITC-dextran in blood on consumption of E. coli (10⁹ cfu/animal/day) due to intestinal damage. Thus, in vivo results confirmed that Lactobacillus fermentum MTCC 5898 is safe and non-toxic to weanling mice and may be considered for functional food application after clinical testing.

中文翻译：

---

重复剂量持续28天（亚急性暴露）后，小鼠模型中潜在的益生菌发酵乳杆菌MTCC-5898的安全性评估。

益生菌的安全评估发酵乳杆菌MTCC-5898（LF）带三个剂量（10 ⁷，10 ⁹和10 ¹¹ （cfu /天/动物）使用口服途径在瑞士的白化病小鼠断奶中进行28天。通过对体重，器官指标，肝和肠的组织学外观进行物理评估以及血液学参数（血红蛋白，白细胞，红细胞计数，MCHC，MCV，MCH），血液中涉及葡萄糖的生化分析物的测量，来监测动物的健康状况，血清酶（ALT，AST和LDH），尿素，肌酐和脂质分布（总胆固醇，甘油三酸酯，HDL，VLDL，LDL和动脉粥样硬化指数）。在实验期间连续食用后，LF对上述总体健康状况的参数没有显示出不利影响。在另一方面，显著增加（p 在TGF-β（调节性细胞因子）和大幅下降≤0.05）（p 摄入10 ⁹  cfu /动物/天时，IFN-γ（促炎性细胞因子）≤0.05）且肠液中IL-4和IL-12没有任何重大变化，证实了其对免疫稳态的剂量特异性反应。此外，与仅口服生理盐水的对照组相比，食用后血液中FITC-右旋糖酐（4 kDa）的释放量无明显变化，也证实了LF的安全性。此外，显著（p  ≤0.05）提高的mRNA表达紧密连接蛋白-1和MUC-2上供给在肠上皮细胞发酵乳杆菌上的消费进一步支持FITC-葡聚糖渗透率数据在血液FITC-葡聚糖的，否则显示出增加的通量ë大肠杆菌（10 ⁹ cfu /动物/天）。因此，体内结果证实发酵乳杆菌MTCC 5898对断奶小鼠安全且无毒，临床试验后可考虑用于功能性食品。