This trial is active, not recruiting.

Conditions hepatic encephalopathy, hypertension, portal, liver cirrhosis
Treatments erythromycin, neomycin
Sponsor UPECLIN HC FM Botucatu Unesp
Collaborator Biophisics Department of Biosciences Institute - Unesp
Start date June 2008
End date June 2010
Trial size 20 participants
Trial identifier NCT01097811, upeclin/HC/FMB-Unesp-41


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
250 mg orally q.i.d.
(Active Comparator)
1 g orally q.i.d.

Primary Outcomes

Recovery of hepatic encephalopathy
time frame: three years

Secondary Outcomes

length of hospitalization caused by hepatic encephalopathy
time frame: three years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.
Principal investigator Fernando G Romeiro
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by UPECLIN HC FM Botucatu Unesp.