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临床试验/NCT02923336
NCT02923336Unknown不适用

Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol)

ALDO TORRE DELGADILLO1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

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

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

Other

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

发起方
ALDO TORRE DELGADILLO
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ALDO TORRE DELGADILLO

MD

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (1)

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