Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial

Conditions
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Hepatic Encephalopathy, Liver Cirrhosis

Intervention / Treatment
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* Dietary Supplement: Lactose-free milk
* Dietary Supplement: Whole milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Diet and lactose-free milk<br>Lactose-free milk | Dietary Supplement: Lactose-free milk<br>* 3.5 g of lactose<br>|
| Active Comparator: Diet and whole milk<br>Whole milk with lactose | Dietary Supplement: Whole milk<br>* Whole milk with 24 g lactose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis | 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. | 30 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in patients with cirrhosis and minimal hepatic encephalopathy | 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. | 30 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Encephalopathy, Liver Cirrhosis, Disaccharides, Lactose, Quality of Life