Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran60 enrolled

Overview

Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. As so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Cirrhosis Minimal Hepatic Encephalopathy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hepatic Cirrhosis * Minimal hepatic Encephalopathy Exclusion Criteria: * Personal history of surgery in the last 4 weeks * Use of neuropsychiatric drugs * Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder) * Thyroid disorders without replacement therapy * Hepatic or renal transplant * Alcoholism with active ingest of alcohol in the last 6 months * Pregnancy * Labour turn-overs * Spontaneous bacterial Peritonitis * Personal history of hepatocellular carcinoma * Placement of transjugular intrahepatic portosystemic shunt * Use of a probiotic in the last 6 months

Outcomes

Primary Outcomes

Reverse minimal hepatic encephalopathy

Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy

Time frame: 3 months

Reverse minimal hepatic encephalopathy

Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy

Time frame: 6 months

Secondary Outcomes

Prevention of progression

Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.