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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Cirrhoses

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propanolol

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.

Group Type EXPERIMENTAL

Propanolol

Intervention Type DRUG

Interventions

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Propanolol

Intervention Type DRUG

Other Intervention Names

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Inderalici

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No