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

This study has suspended participant recruitment.
(We didn't find differences among both groups)
Information provided by (Responsible Party):
Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
First received: April 28, 2010
Last updated: July 28, 2015
Last verified: May 2015
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 Intervention
Hepatic Encephalopathy
Liver Cirrhosis
Dietary Supplement: Lactose-free milk
Dietary Supplement: Whole milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Reversion of Minimal Hepatic Encephalopathy (psychometric test) [ Time Frame: 30 days after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life and blood ammonium [ Time Frame: 30 days after intervention ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Responsible Party: Segundo Moran Villota, Asociado B, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01113567     History of Changes
Other Study ID Numbers: 2010-785-016 
Study First Received: April 28, 2010
Last Updated: July 28, 2015
Health Authority: Mexico: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2016