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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02923336
• Other study ID #: GAS-1068-13/15-1
• Status: Recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2021

Study information

• Verified date: January 2019
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: Aldo Torre Delgadillo
• Email: detoal[@]yahoo.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2021
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán	Mexico	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
ALDO TORRE DELGADILLO

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Chander Roland B, Garcia-Tsao G, Ciarleglio MM, Deng Y, Sheth A. Decompensated cirrhotics have slower intestinal transit times as compared with compensated cirrhotics and healthy controls. J Clin Gastroenterol. 2013 Nov-Dec;47(10):888-93. doi: 10.1097/MCG — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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