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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Coordinación de Investigación en Salud, Mexico.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01113567
First received: April 28, 2010
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

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, critical flicker frequency 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


Condition Intervention Phase
Hepatic Encephalopathy
Liver Cirrhosis
Dietary Supplement: whole milk vs lactose-free milk
Phase 3

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 ]

Estimated Enrollment: 34
Study Start Date: July 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: lactose-free milk Dietary Supplement: whole milk vs lactose-free milk
Whole milk (24 g lactose) vs lactose-free milk (3.5 g of lactose)
Experimental: Lactose Dietary Supplement: whole milk vs lactose-free milk
Whole milk (24 g lactose) vs lactose-free milk (3.5 g of lactose)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01113567

Contacts
Contact: Segundo Moran, MD 525556276900 ext 22363 segundomoran@hotmail.com
Contact: Laura P Bernal, Nut MSc 525556276900 ext 22363 laurapaola_br@hotmail.com

Locations
Mexico
Instituto Mexicano del Seguro Social Recruiting
Mexico, Distrito Federal, Mexico, 06725
Contact: Segundo Moran, MD    525556276900 ext 22363    segundomoran@hotmail.com   
Contact: Laura P Bernal, Nut MSc    525556276900 ext 22363    laurapaola_br@hotmail.com   
Sub-Investigator: Laura P Bernal, Nut MSc         
Sub-Investigator: Margarita Dehesa, M.D.         
Sub-Investigator: Misael Uribe, M.D.         
Sub-Investigator: Nayeli Ortiz, M.D.         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Segundo Moran, MD Instituto Mexicano del Seguro Social
  More Information

Additional Information:
No publications provided

Responsible Party: Segundo Moran Villota, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT01113567     History of Changes
Other Study ID Numbers: 2010-785-016
Study First Received: April 28, 2010
Last Updated: January 3, 2011
Health Authority: Mexico: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 18, 2014