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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01113567
• Other study ID #: 2010-785-016
• Status: Terminated
• Phase: N/A
• Start date: July 2010
• Est. completion date: July 26, 2021

Study information

• Verified date: February 2023
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis
• Liver Diseases

Intervention

Dietary Supplement:
• Lactose-free milk
3.5 g of lactose
• Whole milk
Whole milk with 24 g lactose

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Instituto Mexicano del Seguro Social