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

Not Applicable

• Conditions: Liver Cirrhosis
• Interventions: Drug: non selective beta blocker

• Registration Number: NCT02923336
• Lead Sponsor: ALDO TORRE DELGADILLO

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.

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-10-02
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smart pill	non selective beta blocker	Single group, before and after, the same group is going to be its own control

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán; 🇲🇽 Mexico, Cdmx, Mexico