The First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, Guangdong, China.
Clinical Research Center, The First Affiliated Hospital of Shantou University Medical College (SUMC), Shantou, China.
Trials. 2023 Jun 24;24(1):429. doi: 10.1186/s13063-023-07443-5.
Recent studies have demonstrated a correlation between intestinal flora and the severity of myocardial infarction as well as post-myocardial infarction repair. However, few studies have investigated whether probiotics reduce mortality and improve cardiovascular outcomes in patients with acute myocardial infarction. In this study, we will conduct a randomized controlled trial (RCT) to evaluate the effect of probiotics on in-hospital mortality and the incidence of major adverse cardiovascular events (MACE) in patients with acute myocardial infarction (AMI).
This is an open-label, randomized, controlled, superiority clinical trial involving 2594 adult patients who were diagnosed with acute myocardial infarction. Patients will be randomized to (1) receive bifidobacteria triple viable capsule (Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis) 840 mg, twice a day, plus standard treatment strategy during the hospital stay, for a maximum of 30 days, or (2) receive the standard treatment strategy and will not take the bifidobacterium triple live capsule. The primary outcome was in-hospital all-cause mortality.
The purpose of this clinical trial is to determine whether probiotics can reduce in-hospital mortality and improve prognosis in patients with AMI, and the results will provide evidence for probiotics as a complementary treatment for AMI.
Chinese Clinical Trials Registry ChiCTR2000038797. Registered on 2 October 2020.
最近的研究表明，肠道菌群与心肌梗死的严重程度以及心肌梗死后的修复有关。然而，很少有研究探讨益生菌是否可以降低急性心肌梗死患者的死亡率并改善心血管结局。在这项研究中，我们将进行一项随机对照试验（RCT），以评估益生菌对急性心肌梗死（AMI）患者住院期间死亡率和主要不良心血管事件（MACE）发生率的影响。
这是一项开放标签、随机、对照、优效性临床试验，涉及 2594 名成年 AMI 患者。患者将被随机分为（1）接受双歧杆菌三联活菌胶囊（长双歧杆菌、嗜酸乳杆菌和粪肠球菌）840mg，每日两次，联合住院期间的标准治疗策略，最多 30 天，或（2）接受标准治疗策略，且不服用双歧杆菌三联活菌胶囊。主要结局为住院期间全因死亡率。
本临床试验的目的是确定益生菌是否可以降低 AMI 患者的住院死亡率并改善预后，研究结果将为益生菌作为 AMI 的辅助治疗提供证据。
中国临床试验注册中心 ChiCTR2000038797。于 2020 年 10 月 2 日注册。
