Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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 Identifier:
First received: April 28, 2010
Last updated: August 9, 2016
Last verified: August 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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

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

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

Enrollment: 18
Study Start Date: July 2010
Estimated Study Completion Date: July 2017
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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 Identifier: NCT01113567     History of Changes
Other Study ID Numbers: 2010-785-016
Study First Received: April 28, 2010
Last Updated: August 9, 2016

Keywords provided by Segundo Moran Villota, 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 Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Metabolic Diseases processed this record on May 25, 2017