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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2021-07-26

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.

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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.

Conditions

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Hepatic Encephalopathy Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Diet and lactose-free milk

Lactose-free milk

Group Type PLACEBO_COMPARATOR

Lactose-free milk

Intervention Type DIETARY_SUPPLEMENT

3.5 g of lactose

Diet and whole milk

Whole milk with lactose

Group Type ACTIVE_COMPARATOR

Whole milk

Intervention Type DIETARY_SUPPLEMENT

Whole milk with 24 g lactose

Interventions

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Lactose-free milk

3.5 g of lactose

Intervention Type DIETARY_SUPPLEMENT

Whole milk

Whole milk with 24 g lactose

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No