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

Primary Purpose

Hepatic Encephalopathy, Liver Cirrhosis

Status
Terminated
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lactose-free milk
Whole milk
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, Liver Cirrhosis, Disaccharides, Lactose, Quality of Life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Mexicano del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Diet and lactose-free milk

Diet and whole milk

Arm Description

Lactose-free milk

Whole milk with lactose

Outcomes

Primary Outcome Measures

Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
Improve in Psychometric Hepatic Encephalopathy Score (PHES). The PHES includes five psychometric test: number connectiontests A and B; the digit symbol test; the line tracing test and the serial dotting test. To calculate th PHES, the validated equations for Mexican population will be used. Patients will be diagnosed with MHE when the PHES will be less than -4 points.

Secondary Outcome Measures

Quality of life in patients with cirrhosis and minimal hepatic encephalopathy
Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire (CLDQ). The score of the six domains and the overall CLDQ was calculated with answers presented on a 7-point likert scale, where number 1 referred to the maximum frequency (always) and 7 to the lowest frequency (never). A change of 0.5 on the 1-7 scale aproximates the important difference in questionnaire score.

Full Information

First Posted
April 28, 2010
Last Updated
February 7, 2023
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01113567
Brief Title
Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy
Official Title
Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
erminated [The study was withdrawn because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.]
Study Start Date
July 2010 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Liver Cirrhosis
Keywords
Hepatic Encephalopathy, Liver Cirrhosis, Disaccharides, Lactose, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet and lactose-free milk
Arm Type
Placebo Comparator
Arm Description
Lactose-free milk
Arm Title
Diet and whole milk
Arm Type
Active Comparator
Arm Description
Whole milk with lactose
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactose-free milk
Intervention Description
3.5 g of lactose
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole milk
Intervention Description
Whole milk with 24 g lactose
Primary Outcome Measure Information:
Title
Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
Description
Improve in Psychometric Hepatic Encephalopathy Score (PHES). The PHES includes five psychometric test: number connectiontests A and B; the digit symbol test; the line tracing test and the serial dotting test. To calculate th PHES, the validated equations for Mexican population will be used. Patients will be diagnosed with MHE when the PHES will be less than -4 points.
Time Frame
30 days after intervention
Secondary Outcome Measure Information:
Title
Quality of life in patients with cirrhosis and minimal hepatic encephalopathy
Description
Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire (CLDQ). The score of the six domains and the overall CLDQ was calculated with answers presented on a 7-point likert scale, where number 1 referred to the maximum frequency (always) and 7 to the lowest frequency (never). A change of 0.5 on the 1-7 scale aproximates the important difference in questionnaire score.
Time Frame
30 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Segundo Moran, MD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Mexicano del Seguro Social
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06725
Country
Mexico

12. IPD Sharing Statement

Links:
URL
http://www.imss.gob.mx
Description
Instituto Mexicano del Seguro Social

Learn more about this trial

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

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