多菌株益生菌（多菌株微生物细胞制剂）对2型糖尿病患者血糖控制及其他糖尿病相关结局的影响：一项随机对照试验。
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.
作者信息
Firouzi Somayyeh, Majid Hazreen Abdul, Ismail Amin, Kamaruddin Nor Azmi, Barakatun-Nisak Mohd-Yusof
机构信息
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia.
Department of Social and Preventive Medicine, Faculty of Medicine, Centre for Population Health, University of Malaya, Kuala Lumpur, Malaysia.
出版信息
Eur J Nutr. 2017 Jun;56(4):1535-1550. doi: 10.1007/s00394-016-1199-8. Epub 2016 Mar 17.
AIM
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.
DESIGN
A randomized, double-blind, parallel-group, controlled clinical trial.
SETTING
Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia.
PARTICIPANTS
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.
OUTCOMES
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.
STATISTICAL ANALYSIS
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.
RESULTS
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 µU/mL in placebo group and decreased by 2.9 µU/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.
CONCLUSION
Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.
目的
肠道微生物群与2型糖尿病相关的多个生理过程之间可能存在联系的证据日益增多。然而，多菌株益生菌对2型糖尿病患者的影响仍不明确。本研究调查了多菌株微生物细胞制剂（也称为多菌株益生菌）对2型糖尿病患者血糖控制及其他糖尿病相关结局的影响。
设计
一项随机、双盲、平行组对照临床试验。
地点
马来西亚吉隆坡一家教学医院的糖尿病诊所。
参与者
共招募了136名年龄在30 - 70岁的2型糖尿病患者，并随机分为两组，分别接受益生菌治疗（n = 68）或安慰剂治疗（n = 68），为期12周。
结局指标
主要结局指标为血糖控制相关参数，次要结局指标为人体测量学变量、血脂谱、血压和高敏C反应蛋白。干预前后测量乳酸杆菌和双歧杆菌数量，作为补充剂成功通过胃肠道的指标。
统计分析
对所有参与者进行意向性分析（ITT），对依从率良好且成功完成试验的参与者进行符合方案分析（PP）。
结果
关于主要结局指标，在符合方案分析中，益生菌组糖化血红蛋白下降了0.14%，安慰剂组上升了0.02%（p < 0.05，效应量小，为0.050），而在意向性分析中这些变化不显著。在符合方案分析中，安慰剂组空腹胰岛素增加了1.8 μU/mL，益生菌组下降了2.9 μU/mL。在两种分析中，两组间这些变化均有显著性差异（p < 0.05，符合方案分析中效应量中等，为0.062，意向性分析中效应量小，为0.033）。次要结局指标无显著变化。益生菌成功通过胃肠道。
结论
益生菌适度改善了2型糖尿病患者的糖化血红蛋白和空腹胰岛素水平。
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