Hepatic Cirrhosis, Hepatic Encephalopathy
Conditions
Interventions
Intervention group: 21 cirrhotic patients with hepatic encephalopathy will receive a supplement consisting of the amino acid isoleucine in a 10g sachet, which will administered 3 times daily (total 30
Control group: 21 cirrhotic patients with hepatic encephalopathy will receive a supplement consisting of the amino acid leucine in a 10g sachet, which will be administered 3 times daily (total 30g)
The groups will be distributed by a randomized list generated by a computer.
The duration of the intervention of both groups will be of 1 year (52 weeks on average).
Dietary supplement
D12.125.070.577
Sponsors
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista Julio de Mesquita Filho
Ajinomoto - Divisão Aminoscience Brasil
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactLaís Augusti
Faculdade de Medicina de Botucatu - Universidade Estadual Paulista Julio de Mesquita Filho
Outcome results
None listed