NCT01113567

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy
• Liver Cirrhosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactose-free milk	3.5 g of lactose
DIETARY_SUPPLEMENT	Whole milk	Whole milk with 24 g lactose

Timeline

• Start date: 2010-07-01
• Primary completion: 2021-07-26
• Completion: 2021-07-26
• First posted: 2010-04-30
• Last updated: 2023-02-09

Locations

1 site across 1 country: Mexico