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

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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Cirrhosis; Hepatic Encephalopathy
• Intervention / Treatment: Dietary supplement: Lactose-free milk; Dietary supplement: Whole milk

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06725
      • Instituto Mexicano del Seguro Social

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Diet and lactose-free milk; Lactose-free milk	Dietary supplement: Lactose-free milk; 3.5 g of lactose
ACTIVE_COMPARATOR: Diet and whole milk; Whole milk with lactose	Dietary supplement: Whole milk; Whole milk with 24 g lactose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico

Publications and helpful links

Helpful Links

• Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2010
• Primary Completion (ACTUAL): July 26, 2021
• Study Completion (ACTUAL): July 26, 2021

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (ESTIMATE): April 30, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Quality of Life; Hepatic Encephalopathy; Disaccharides; Lactose
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic; Liver Diseases; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: 2010-785-016