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

Sponsor

ALDO TORRE DELGADILLO (Other)

Overall Status

Unknown status

CT.gov ID

NCT02923336

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis	Drug: non selective beta blocker	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Smart pill Single group, before and after, the same group is going to be its own control	Drug: non selective beta blocker 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 Other Names: propranolol

Arm

Intervention/Treatment

Other: Smart pill

Single group, before and after, the same group is going to be its own control

Drug: non selective beta blocker

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

Other Names:

propranolol

Outcome Measures

Primary Outcome Measures

Gastrointestinal transit time before and after treatment with no selective betablocker [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 [4 weeks of maximum non betablocker dose]
gene expression of tight junctions proteins in duodenal and gastric epithelium

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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