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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01113567
Recruitment Status : Suspended (We didn't find differences among both groups)
First Posted : April 30, 2010
Last Update Posted : August 10, 2016
Information provided by (Responsible Party):
Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Liver Cirrhosis Dietary Supplement: Lactose-free milk Dietary Supplement: Whole milk Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial
Study Start Date : July 2010
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Placebo Comparator: Diet and lactose-free milk
Lactose-free milk
Dietary Supplement: Lactose-free milk
3.5 g of lactose

Active Comparator: Diet and whole milk
Whole milk with lactose
Dietary Supplement: Whole milk
Whole milk with 24 g lactose

Primary Outcome Measures :
  1. Reversion of Minimal Hepatic Encephalopathy (psychometric test) [ Time Frame: 30 days after intervention ]

Secondary Outcome Measures :
  1. Quality of life and blood ammonium [ Time Frame: 30 days after intervention ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01113567

Instituto Mexicano del Seguro Social
Mexico, Distrito Federal, Mexico, 06725
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Principal Investigator: Segundo Moran, MD Instituto Mexicano del Seguro Social

Additional Information:
Responsible Party: Segundo Moran Villota, Asociado B, Coordinación de Investigación en Salud, Mexico Identifier: NCT01113567     History of Changes
Other Study ID Numbers: 2010-785-016
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico:
Hepatic Encephalopathy
Liver Cirrhosis
Quality of Life

Additional relevant MeSH terms:
Hepatic Encephalopathy
Liver Diseases
Brain Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases