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临床试验/NCT04775329
NCT04775329终止2 期

Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial

Changi General Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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