Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Incidence of Spontaneous bacterial peritonitis
研究概览
简要总结
Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. It is postulated that in cirrhosis, endotoxins translocate across the gut mucosal barrier resulting in a second hit within hepatocyte perpetuating decompensation and spontaneous bacterial peritonitis. We hypothesise that cirrhosis patients with concomitant SIBO are particularly vulnerable for endotoxin translocation and would benefit from treatment. Treatment of SIBO would reduce the risk of spontaneous bacterial peritonitis and other liver-related morbidities. We aim to treat a cohort of patients with severe liver disease and concomitant SIBO with antibiotics as prophylaxis and compare the risk of spontaneous bacterial peritonitis, further liver-related morbidity and survival against untreated asymptomatic controls.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomised, placebo-controlled study
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Decompensated liver cirrhosis (Childs B & C) with ascites.
- •Established diagnosis of SIBO
排除标准
- •Known allergy to treatment drugs
- •Inability to undergo test confirm the success of SIBO eradication;
- •Pregnant or lactating women
- •Terminal malignancy.
- •Untreated Viral Hepatitis
- •Alcoholic Liver disease with ongoing drinking.
- •Respiratory Failure
- •Recent antibiotics and proton-pump inhibitor within 30 days
研究组 & 干预措施
Treatment arm
干预措施: Rifaximin (Drug)
结局指标
主要结局
Incidence of Spontaneous bacterial peritonitis
时间窗: 12 months
To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.
次要结局
- Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)(12 months)
