Centre for Research & Development, Unique Biotech Ltd., Alexandria Knowledge Park, Hyderabad, Telangana, India.
Life Veda Treatment and Research Centre, Worli, Mumbai, India.
PLoS One. 2019 Nov 13;14(11):e0225168. doi: 10.1371/journal.pone.0225168. eCollection 2019.
Role of multi-strain probiotic formulations in the management of type 2 diabetes mellitus (T2DM) has rarely been reported. In the present study, the effects of the probiotic formulation, UB0316 (L. salivarius UBLS22, L. casei UBLC42, L. plantarum UBLP40, L. acidophilus UBLA34, B. breve UBBr01, B. coagulans Unique IS2, 5 billion CFU each and fructo-oligosaccharides, 100 mg) in patients with T2DM were assessed.
A total of 79 eligible subjects (18-65 years, on stable metformin therapy) were randomly assigned to receive UB0316 or placebo, twice-a-day for 12 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c), secondary were assessment of blood glucose levels, HOMA-IR (homeostatic model assessment of insulin resistance), insulin, body weight, and blood lipids. Quality of life, vital signs, physical investigations, safety and Physician/Subject's Global assessment were also evaluated.
Twelve week multi-strain probiotic (UB0316) supplementation significantly reduced HbA1c (7.70 ± 0.79%; p = 0.0023) and weight (67.00 ± 8.82 kg; p < 0.001) as compared to placebo (HbA1c: 8.30 ± 1.35%; weight: 67.60 ± 9.46 kg). The changes recorded in fasting blood glucose (FBG), HOMA-IR, insulin, TC, TG, HDL, and LDL levels were however not significantly altered as compared to placebo. No severe adverse events, abnormal vital and physical signs were reported. The quality of life of T2DM was significantly improved.
UB0316 significantly improved glycemic control as indicated by the decrease in HbA1c levels. There was also a significant decrease in weight in the probiotic treated subjects as compared to placebo.
多菌株益生菌配方在 2 型糖尿病（T2DM）管理中的作用鲜有报道。在本研究中，评估了益生菌制剂 UB0316（唾液乳杆菌 UBLS22、干酪乳杆菌 UBLC42、植物乳杆菌 UBLP40、嗜酸乳杆菌 UBLA34、短双歧杆菌 UBBr01、凝结芽孢杆菌 Unique IS2，每种菌均为 50 亿 CFU 和低聚果糖 100mg）对 T2DM 患者的影响。
共有 79 名符合条件的受试者（年龄 18-65 岁，服用稳定剂量二甲双胍治疗）被随机分为 UB0316 组或安慰剂组，每天 2 次，疗程 12 周。主要终点为糖化血红蛋白（HbA1c）的变化，次要终点为血糖水平、稳态模型评估的胰岛素抵抗指数（HOMA-IR）、胰岛素、体重和血脂的评估。生活质量、生命体征、体格检查、安全性和医生/患者总体评估也进行了评估。
12 周多菌株益生菌（UB0316）补充治疗可显著降低 HbA1c（7.70 ± 0.79%；p = 0.0023）和体重（67.00 ± 8.82kg；p < 0.001），与安慰剂相比（HbA1c：8.30 ± 1.35%；体重：67.60 ± 9.46kg）。然而，与安慰剂相比，空腹血糖（FBG）、HOMA-IR、胰岛素、TC、TG、HDL 和 LDL 水平的变化没有明显改变。未报告严重不良事件和异常生命体征及体格检查结果。T2DM 的生活质量显著改善。
UB0316 可显著改善血糖控制，表现为 HbA1c 水平降低。与安慰剂相比，益生菌治疗组的体重也显著下降。
