Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy
Recruitment status was Recruiting
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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 |
- Reversion of Minimal Hepatic Encephalopathy (psychometric test) [ Time Frame: 30 days after intervention ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Segundo Moran, MD | 525556276900 ext 22363 | segundomoran@hotmail.com |
| Contact: Laura P Bernal, Nut MSc | 525556276900 ext 22363 | laurapaola_br@hotmail.com |
| 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. | |
| 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 Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes Liver Failure Hepatic Insufficiency Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Metabolic Diseases Pathologic Processes Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 19, 2013