Evaluation of Intestinal Permeability in Cirrhotic Patients Before and After Treatment With Non-selective Beta Blocker (Propranolol)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Unknown

Conditions: Liver Cirrhoses

Treatments: Drug: Propanolol

Study type: Interventional

Funder types: Other

Identifiers

NCT02484573

GAS-1116-14/15-1

Details and patient eligibility

About

This study seeks to investigate whether non-selective beta blocker treatment decreases intestinal permeability in cirrhotic patients by altering the expression of genes encoding intercellular junction proteins.

Full description

There is evidence that the non-selective beta-blocker (NSBB) propranolol reduces intestinal permeability and decreases bacterial translocation in cirrhotic patients, independent of hemodynamic effects on portal pressure. The mechanism by which this decrease in intestinal permeability and bacterial translocation occurs has not been established. Among the proposed mechanisms are: modification of splanchnic hemodynamics, increased gastrointestinal motility, and immunological properties of nonselective beta blockade. It is not known, however, if beta-blocker treatment decreases intestinal permeability by altering the expression of genes encoding intercellular junction proteins. This study seeks to investigate this question to improve understanding of the mechanism by which beta-blockers work in primary and secondary prophylaxis of variceal hemorrhage.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years
• Diagnosis of cirrhosis of any etiology or severity as established by the treating physician (biopsy, biochemical, imaging)
• High risk gastroesophageal varices, that is those with medium/large varices or any size varices with red wale signs
• Scheduled appointment for endoscopic ligation as previously ordered by the treating physician
• Signed informed consent
• Ability to keep return appointments

Exclusion criteria

• Beta blocker treatment within 1 month prior to study period
• Antibiotic treatment during or within 1 month prior to study period
• Prebiotic or probiotic treatment during or within 1 month before study period
• Current immunosuppressive treatment
• Patients with active infectious process
• Patients with portal thrombosis
• Patients with hepatocellular carcinoma
• Patients with intestinal surgical shunts
• Patients with chronic diarrhea or documented celiac disease
• Patients with chronic renal failure (KDOQI: ≤ 3)
• Patients with allergy or absolute contraindication for the use of nonselective beta blockers (asthma, significant heart block, systolic BP <90 mm Hg, basal HR <55, refractory ascites)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Propanolol

Experimental group

Description:

Patients will take the non-selective beta blocker propranolol for approximately 4 weeks starting immediately after endoscopy for esophageal variceal ligation. Patients will be initiated on a dose of 20mg by mouth every 12 hrs before titration to maximum tolerated dose. Patients will undergo testing before and after treatment for the variables listed in the outcomes section below.

Treatment:

Drug: Propanolol