Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Gastrointestinal transit time before and after treatment with no selective betablocker
研究概览
简要总结
The purpose of this study is to evaluate the influence of non betablockers in gastrointestinal motility (transit time) in patients with liver cirrhosis.
详细描述
There is some evidence that cirrhotic patients have increased gastrointestinal transit time, this issue may favor bacterial owergrowth, and consequently bacterial translocation. Translocation of bacterias and its products are linked to vascular and hemodynamics alterations that produce descompensation on the disease. There is evidence , in animal models , that the use of beta blockers favors the gastrointestinal movement; decompensated cirrhotics had significantly longer small bowel transit time as compared with compensated cirrhotics, there have described that this alteration is related to de cirrhosis severity as assessed by Child Pugh score. The purpose of this study is to evaluate the gastrointestinal transit time before and after treatment of non selective betablockers, we are going to evaluate the gastrointestinal time before and after of 4 weeks of non selectivebetablocker treatment, in decompensated cirrhotics. The gastrointestinal time is going to be evaluate by the ingestion of a device known as "smart pill", that allow ambulatory monitoring of gastrointestinal transit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis of any ethiology
- •Child Pugh A, B, C without beta-blocker treatment previously (min. 1 month without treatment)
- •Patients with previous variceal bleeding (with liver cirrhosis) * Patients with ascites or bacterial spontaneous peritonitis
排除标准
- •Variceal disease without cirrhosis
- •Cirrhotics patients that use antibiotics, prebiotics and probiotics during the study period and one month previously
- •Patients under immunosuppressor treatment
- •Patients with portal thrombosis
- •Patients with Sd. Budd-Chiari or cava/suprahepatic thrombosis
- •Patients with active infection process
研究组 & 干预措施
Smart pill
Single group, before and after, the same group is going to be its own control
干预措施: non selective beta blocker (Drug)
结局指标
主要结局
Gastrointestinal transit time before and after treatment with no selective betablocker
时间窗: 4 weeks of maximum non betablocker dose
gastrointestinal time evaluated by a device called Smart pill
Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker
时间窗: 4 weeks of maximum non betablocker dose
gene expression of tight junctions proteins in duodenal and gastric epithelium
次要结局
未报告次要终点
研究者
ALDO TORRE DELGADILLO
MD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
