Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the influence of non betablockers in gastrointestinal motility (transit time) in patients with liver cirrhosis.

Detailed Description
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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.

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: non selective beta blocker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Smart pill<br>Single group, before and after, the same group is going to be its own control | Drug: non selective beta blocker<br>* the patient is going to receive a device called smart pill before the beginning of treatment with propranolol, after the evaluation with the smart pill device, they are goning to take propranolol (dose of propranolol 80 mg per day) for 4 weeks,finally they will receive another smart pill to evaluate the second gastrointestinal transit time<br>* Other names: propranolol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal transit time before and after treatment with no selective betablocker | gastrointestinal time evaluated by a device called Smart pill | 4 weeks of maximum non betablocker dose | 
| Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker | gene expression of tight junctions proteins in duodenal and gastric epithelium | 4 weeks of maximum non betablocker dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cirrhosis, variceal bleeding, non selective beta blockers