Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Acute Gastrointestinal Injury
研究概览
简要总结
Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms related to CVDs. The potential therapeutic strategies for primary care practitioners included the modulation of the gut microbiome through dietary changes, prebiotics, and probiotics. The aim of this study was to investage the effect of gut microbiome modulation on clinical outcomes after cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of this research, we could not keep the participants blind to group assignment, but the study staff and statistical analyses were all blind to patient allocation during datacollection.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women;
- •Cardiovascular surgery;
- •Agree to participate in the study and sign the informed consent form.
排除标准
- •Pregnant women;
- •Patients with preexisting psychotic disorders;
- •Decline to participate in the study.
研究组 & 干预措施
Intestinal Microbial Transformation (IMT)
The Intestinal Microbial Transformation (IMT) group received Probacine, in addition to standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports.
干预措施: Intestinal Microbiota Transplant (IMT) Capsules (Drug)
Control
The control group received standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports.
结局指标
主要结局
Acute Gastrointestinal Injury
时间窗: 14 days after surgery
次要结局
- ΔSOFA(7 days after surgery)
- 30-day mortality rate(30 days after surgery)
研究者
Hong Liu
Investigator of Cardio-Thoracic Surgery
Nanjing Medical University