Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial
Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial
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DOI：
10.1007/s00394-016-1199-8
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发表时间：
2017-06-01
影响因子：
5
通讯作者：
Barakatun-Nisak, Mohd-Yusof
中科院分区：
文献类型：
--
作者：
Firouzi, Somayyeh;Majid, Hazreen Abdul;Barakatun-Nisak, Mohd-Yusof
越来越多的证据表明肠道微生物群和与 2 型糖尿病相关的几种生理过程之间可能存在联系。然而，多菌株益生菌对 2 型糖尿病患者的作用仍不清楚。本研究调查了多菌株微生物细胞制剂（也指多菌株益生菌）对 2 型糖尿病患者的血糖控制和其他糖尿病相关结果的影响。一项随机、双盲、平行组、对照临床试验。马来西亚吉隆坡一家教学医院的糖尿病诊所。招募了 136 名年龄 30-70 岁的 2 型糖尿病参与者，并随机分配接受益生菌治疗（n = 68）或安慰剂（n = 68），持续12周。主要结果是血糖控制相关参数，次要结果是拟人化变量、血脂、血压和高敏C反应蛋白。在干预前后测量乳酸杆菌和双歧杆菌的数量，作为补充剂成功通过胃肠道的指标。对所有参与者进行意向治疗（ITT）分析，对那些以良好依从性成功完成试验的参与者进行符合方案（PP）分析。就主要结果而言，益生菌组中的糖化血红蛋白降低了 0.14%，安慰剂组中糖化血红蛋白增加了 0.02% PP 分析（p < 0.05，效应量较小，为 0.050），而这些变化在 ITT 分析中并不显着。 PP 分析中，安慰剂组空腹胰岛素增加 1.8 A mu U/mL，益生菌组减少 2.9 A mu U/mL。在两项分析中，这些变化在各组之间都很显着（p < 0.05，PP 分析中的中等效应大小为 0.062，ITT 分析中的小效应大小为 0.033）。次要结果没有显着变化。益生菌成功通过胃肠道。益生菌可适度改善 2 型糖尿病患者的 HbA1c 和空腹胰岛素水平。
Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes.A randomized, double-blind, parallel-group, controlled clinical trial.Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia.A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks.Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract.Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate.With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 A mu U/mL in placebo group and decreased by 2.9 A mu U/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract.Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.