Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

Overview

Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded.

Full Title of Study: “Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2010

Interventions

  • Drug: Erythromycin
    • 250 mg orally q.i.d.
  • Drug: Neomycin
    • 1 g orally q.i.d.

Arms, Groups and Cohorts

  • Active Comparator: Erythromycin
  • Active Comparator: Neomycin

Clinical Trial Outcome Measures

Primary Measures

  • Recovery of hepatic encephalopathy
    • Time Frame: three years
    • comparison of efficacy between two drugs for the treatment of hepatic encephalopathy

Secondary Measures

  • length of hospitalization caused by hepatic encephalopathy
    • Time Frame: three years
    • comparison of efficacy between two drugs for reducing the length of hospitalization during treatment of hepatic encephalopathy

Participating in This Clinical Trial

Inclusion Criteria

  • Hepatic cirrhosis or portal hypertension
  • Hepatic Encephalopathy

Exclusion Criteria

  • Acute liver failure
  • Neuropsychiatric diseases
  • Inflammatory bowel diseases
  • Intestinal obstruction
  • Shock
  • Renal insufficiency
  • Alcoholic hepatitis
  • Alcohol abuse
  • Antibiotic premedication

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UPECLIN HC FM Botucatu Unesp
  • Collaborator
    • Biophisics Department of Biosciences Institute – Unesp
  • Provider of Information About this Clinical Study
    • Fernando Gomes Romeiro / Doctor, Faculdade de Medicina de Botucatu – UNESP
  • Overall Official(s)
    • Fernando G Romeiro, Principal Investigator, Faculdade de Medicina de Botucatu, Unesp
    • Carlos A Caramori, Study Chair, Faculdade de Medicina de Botucatu, Unesp

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