Department of Geriatrics and National Clinical Research Center for Geriatrics, West China Hospital of Sichuan University, Chengdu, China.
Front Endocrinol (Lausanne). 2024 Sep 16;15:1440286. doi: 10.3389/fendo.2024.1440286. eCollection 2024.
This double-blind, placebo-controlled, randomized (1:1) clinical trial was conducted at the West China Hospital, Sichuan University, from March to September 2017.
Eligible participants included adults aged 18 years and older, living in the community, diagnosed with type 2 Diabetes Mellitus according to ADA guidelines, capable of self-managing their diabetes, and able to visit the study site for follow-up. The intervention group received 25 ml of a probiotic beverage containing with over 10^8 CFU/mL of Lactobacillus, administered four times daily. An equal volume of inactivated Lactobacillus was administered to the control group and the control group was administered the same volume of inactivated Lactobacillus. This study aimed to evaluate the effectiveness of probiotics on glycemic control and other diabetes-related outcomes in patients with type 2 diabetes patients. The primary outcomes were changes in HbA1c and FBG levels post-intervention. Investigators, participants, and study site personnel were blinded to the treatment allocation until the conclusion of the study. This double-blind, randomized, placebo-controlled clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR-POR-17010850).
Of the 490 participants screened, 213 were randomized to either the probiotics group (n = 103) or the placebo group (n = 110). After 16 weeks of follow-up, the probiotic group showed reductions in HbA1c [-0.44 (-0.66 to -0.22)] and FBG [-0.97 (-1.49 to 0.46)] post-intervention, similar to the placebo group with reductions in HbA1c [-0.33 (-0.52 to -0.15)] and FBG [-0.90 (-1.32 to -0.47)], but these changes were not statistically significant in PP and ITT analyses (P>0.05). Adverse events were similarly distributed among groups, indicating comparable safety profiles.
Overall, 16-week probiotic supplementation showed no beneficial effects on glycemic control, lipid profiles, or weight.
https://www.chictr.org.cn/showproj.html?proj=18421, identifier ChiCTR-POR-17010850.
本研究为一项双盲、安慰剂对照、随机（1:1）临床试验，于 2017 年 3 月至 9 月在四川大学华西医院进行。
符合条件的参与者为年龄 18 岁及以上、居住在社区、符合 ADA 指南诊断标准的 2 型糖尿病成人、能够自我管理糖尿病、且能够到研究现场进行随访。干预组每天接受 4 次含有超过 10^8 CFU/mL 嗜酸乳杆菌的益生菌饮料 25ml，对照组接受等量的灭活嗜酸乳杆菌。本研究旨在评估益生菌对 2 型糖尿病患者血糖控制和其他糖尿病相关结局的影响。主要结局为干预后 HbA1c 和 FBG 水平的变化。研究者、参与者和研究现场人员在研究结束前对治疗分配保持盲态。这项双盲、随机、安慰剂对照的临床试验在中国临床试验注册中心（ChiCTR-POR-17010850）注册。
在 490 名筛选的参与者中，213 名被随机分配到益生菌组（n = 103）或安慰剂组（n = 110）。经过 16 周的随访，益生菌组在干预后 HbA1c[-0.44（-0.66 至-0.22）]和 FBG[-0.97（-1.49 至 0.46）]降低，与安慰剂组 HbA1c[-0.33（-0.52 至-0.15）]和 FBG[-0.90（-1.32 至-0.47）]的降低相似，但在 PP 和 ITT 分析中这些变化均无统计学意义（P>0.05）。不良事件在各组间的分布相似，表明安全性相似。
总体而言，16 周的益生菌补充剂对血糖控制、血脂谱或体重没有有益影响。
https://www.chictr.org.cn/showproj.html?proj=18421，标识符 ChiCTR-POR-17010850。
