Clinical trial NCT01113567: Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy
Official title: Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatic Encephalopathy
Liver Cirrhosis
Keywords: Hepatic Encephalopathy
Liver Cirrhosis
Disaccharides
Lactose
Quality of Life
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2010-04-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
timeFrame: 30 days after intervention
Secondary outcomes:
measure: Quality of life in patients with cirrhosis and minimal hepatic encephalopathy
timeFrame: 30 days after intervention
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Distrito Federal
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Segundo Moran, MD
role: PRINCIPAL_INVESTIGATOR
References: