Hepatic Encephalopathy, Liver Cirrhosis
Conditions
Keywords
Hepatic Encephalopathy, Liver Cirrhosis, Disaccharides, Lactose, Quality of Life
Brief summary
Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive lactose-free milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days. An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.
Detailed description
Mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. One of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (MHE), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. There are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. The administration of non-absorbable disaccharides has been proven to ameliorate MHE. Lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of MHE. The aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.
Interventions
DIETARY_SUPPLEMENTLactose-free milk
3.5 g of lactose
DIETARY_SUPPLEMENTWhole milk
Whole milk with 24 g lactose
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic liver disease of whichever etiology * Minimal hepatic encephalopathy * Lactose maldigestion
Exclusion criteria
* Patients with clinical manifestations of hepatic encephalopathy * Recent use of antibiotics or psychotropic drugs * Recent use of alcohol abuse * Gastrointestinal bleeding * Others neurological disorders that affect the psychometric test * Chronic renal failure * Congestive heart failure * Chronic Obstructive Pulmonary Disease * Severe symptoms of lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis | 30 days after intervention | Improve in Psychometric Hepatic Encephalopathy Score (PHES). The PHES includes five psychometric test: number connectiontests A and B; the digit symbol test; the line tracing test and the serial dotting test. To calculate th PHES, the validated equations for Mexican population will be used. Patients will be diagnosed with MHE when the PHES will be less than -4 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life in patients with cirrhosis and minimal hepatic encephalopathy | 30 days after intervention | Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire (CLDQ). The score of the six domains and the overall CLDQ was calculated with answers presented on a 7-point likert scale, where number 1 referred to the maximum frequency (always) and 7 to the lowest frequency (never). A change of 0.5 on the 1-7 scale aproximates the important difference in questionnaire score. |
Countries
Mexico
Outcome results
None listed