Supplementation of different branched chain amino acids in the treatment of hepatic encephalopathy in cirrhotic patients: randomized, double-blind, controlled trial

Not Applicable

• Conditions: Hepatic Cirrhosis, Hepatic Encephalopathy; C06.552.308.500.356; C06.552.630

• Registration Number: RBR-8t4bf3
• Lead Sponsor: Faculdade de Medicina de Botucatu - Universidade Estadual Paulista Julio de Mesquita Filho

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Literate individuals aged over 18 years; Presence of cirrhosis (defined by liver biopsy or by a combination of clinical criteria: physical examination with signs of liver failure and / or portal hypertension, endoscopic examination with the presence of esophageal or gastric varices, and / or radiological imaging, ultrasound or computed tomography abdominal, with evidence of chronic liver disease and / or portal hypertension); Presence of Hepatic Encephalopathy (HE) type C ranging from Minimal Hepatic Encephalopathy (MHE) to grade III.

Exclusion Criteria

Fulminant hepatic failure (Hepatic Encephalopathy type A); Hepatic Encephalopathy (HE) secondary to porto-systemic shunts without intrinsic liver disease (HE type B); Severe neuropsychiatric disorders; Obstruction or inflammatory bowel disease; Severe renal impairment (serum creatinine greater than twice normal); Shock (septic, hemorrhagic, neurogenic, cardiac, anaphylactic or mixed); Misuse of alcohol or alcoholic hepatitis in the last six weeks; Use of food supplement with Branched Chain Amino Acids (BCAA); HE grade IV; Recent use of lactulose, antibiotics or L-ornithine L-aspartate (If these medications are started less than a week of the initial intake of the suplementation, the patient will be temporarily excluded from the study, however, chronic use will not be considered an exclusion criterion); Patients in treatment of hepatitis C; Neoplasia; Pregnancy, Lactation and Obesity.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify which branched chain amino acid (leucine or isoleucine) is more efficient in the treatment of hepatic encephalopathy and nutritional disorders in patients with cirrhosis.

Secondary Outcome Measures

Name	Time	Method
Analyze the ammonia, albumin and branched chain amino acids serum values before, during and after the treatment in order to evaluate the treatment effects.;Observe the impact of the supplementation on quality of life according to the results of the questionnaire applied at the beginning and end of treatment.