Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy


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


  • 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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