NCT06134544招募中不适用
Effect of Isomaltooligosaccharides on Intestinal Bacterial Translocation in Patients With Liver Cirrhosis: a Single-center, Single-arm Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Changes of Lipopolysaccharide (LPS) in plasma
研究概览
简要总结
The goal of this intervention clinical trial is to learn about the protection of isomaltooligosaccharides (IMO) on intestinal bacterial translocation in patients with liver cirrhosis. The main question is to answer the changes of LPS after adminstration of IMO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18-
- •Cirrhotic patients.
- •Decompensation event: ascites.
- •LPS>0.45EU/ml.
排除标准
- •Pregnant or breast-feeding.
- •Active bacterial or fungal infection.
- •Other decompensations: Hepatic encephalopathy, gastroesophageal varices and hemorrhage.
- •Diagnosis of EASL-ACLF.
- •Diarrhea.
- •Malignancy.
- •Anticipated short survival time.
- •Adverse reactions or allergies to oral carbohydrate preparations.
- •Substance abuse or addiction.
- •Severe extrahepatic diseases (e.g. patients with CKD-5 stage, severe cardiopulmonary dysfunction, and psychiatric disorders).
- •Be immunosuppressed or immunodeficient states and the use of immunoglobulins or other immune-boosting conditions.
- •Be unsuitable for participating in this trial.
- •Participated in any drug trial within the past month
- •History of antibacterial or fungal use within 1 week prior to screening
结局指标
主要结局
Changes of Lipopolysaccharide (LPS) in plasma
时间窗: Before (Day-0) and after treatment (Day-8).
LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test
次要结局
- Changes of markers of infections (PCT) in plasma(Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).)
- Changes of markers of kidney failure (Cr) in plasma(Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).)
- Changes of markers of coagulation failure (INR) in plasma(Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).)
- Changes of bacterial load in plasma(Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).)
- Changes of markers of infections (CRP) in plasma(Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).)
- Changes of markers of liver failure (TBIL) in plasma(Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).)
- Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment(After 7-day non-treatment (day 15).)
- Changes of Meld scores which evaluate severity of liver diseases.(Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).)
- Incidence of bacterial infection(After treatment (Day-8) up to follow-up (Day-28))
- Development of acute-on-chronic liver failure(After treatment (Day-8) up to follow-up (Day-28))
- 28-day mortality(Day-28)
研究者
研究点 (1)
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