Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.

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

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Hepatic Encephalopathy; Hypertension, Portal
• Intervention / Treatment: Drug: Erythromycin; Drug: Neomycin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618970
      • Faculdade de Medicina de Botucatu - Universidade Estadual Paulista

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erythromycin	Drug: Erythromycin; 250 mg orally q.i.d.
Active Comparator: Neomycin	Drug: Neomycin; 1 g orally q.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of hepatic encephalopathy	comparison of efficacy between two drugs for the treatment of hepatic encephalopathy	three years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UPECLIN HC FM Botucatu Unesp
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Biophisics Department of Biosciences Institute - Unesp
• Investigators: Principal Investigator: Fernando G Romeiro, Faculdade de Medicina de Botucatu, Unesp; Study Chair: Carlos A Caramori, Faculdade de Medicina de Botucatu, Unesp

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: March 31, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2010
• Last Update Submitted That Met QC Criteria: April 27, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Hepatic Encephalopathy; Hypertension, Portal; Bacterial Overgrowth Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Fibrosis; Hypertension; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Hypertension, Portal; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Neomycin
• Other Study ID Numbers: upeclin/HC/FMB-Unesp-41