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

ALDO TORRE DELGADILLO

Status: Unknown

Conditions: Liver Cirrhosis

Treatments: Drug: non selective beta blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT02923336

GAS-1068-13/15-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Smart pill

Other group

Description:

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

Treatment:

Drug: non selective beta blocker