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Introduction: 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.
Objective: to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.
Methodology: Double-blind, randomized, controlled clinical trial. Setting: Patients from the Gastroenterology Research Laboratory at "Centro Médico Nacional Siglo XXI" (IMSS) Mexico City with diagnosis of chronic liver disease of whichever etiology, minimal hepatic encephalopathy and lactose maldigestion.
Intervention: Two groups of patients with MHE 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 and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days.
Study variables: minimal hepatic encephalopathy, quality of life and blood ammonium.
Randomization: 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.
Double blind: the researchers and patients will not have information on the assignation of treatment.
Ethical precepts: The study protocol was designed according to the CONSORT (Consolidated Standards of Reporting Trials) and was approved by the IMSS´s National Commission of Scientific Research. The informed consent will be written in accordance to the Declaration of Helsinki, the dispositions of the Health Secretariat in Human Research and the requirements of the Ethics Commission.
Interest conflict: none
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
whole milk vs lactose-free milk
Instituto Mexicano del Seguro Social
Not yet recruiting
Coordinación de Investigación en Salud, Mexico
Published on BioPortfolio: 2014-07-23T21:09:23-0400
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