Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01113567
Status:
TERMINATED
Last Update Posted:
2023-02-09
First Post:
2010-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'erminated \\[The study was withdrawn because of the reconversion of the hospital to care for patients with COVID19.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.\\]', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2010-04-28', 'studyFirstSubmitQcDate': '2010-04-29', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis', 'timeFrame': '30 days after intervention', '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.'}], 'secondaryOutcomes': [{'measure': 'Quality of life in patients with cirrhosis and minimal hepatic encephalopathy', 'timeFrame': '30 days after intervention', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatic Encephalopathy', 'Liver Cirrhosis', 'Disaccharides', 'Lactose', 'Quality of Life'], 'conditions': ['Hepatic Encephalopathy', 'Liver Cirrhosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.imss.gob.mx', 'label': 'Instituto Mexicano del Seguro Social'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic liver disease of whichever etiology\n* Minimal hepatic encephalopathy\n* Lactose maldigestion\n\nExclusion Criteria:\n\n* Patients with clinical manifestations of hepatic encephalopathy\n* Recent use of antibiotics or psychotropic drugs\n* Recent use of alcohol abuse\n* Gastrointestinal bleeding\n* Others neurological disorders that affect the psychometric test\n* Chronic renal failure\n* Congestive heart failure\n* Chronic Obstructive Pulmonary Disease\n* Severe symptoms of lactose intolerance'}, 'identificationModule': {'nctId': 'NCT01113567', 'briefTitle': 'Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': 'Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2010-785-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Diet and lactose-free milk', 'description': 'Lactose-free milk', 'interventionNames': ['Dietary Supplement: Lactose-free milk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diet and whole milk', 'description': 'Whole milk with lactose', 'interventionNames': ['Dietary Supplement: Whole milk']}], 'interventions': [{'name': 'Lactose-free milk', 'type': 'DIETARY_SUPPLEMENT', 'description': '3.5 g of lactose', 'armGroupLabels': ['Diet and lactose-free milk']}, {'name': 'Whole milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Whole milk with 24 g lactose', 'armGroupLabels': ['Diet and whole milk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06725', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Mexicano del Seguro Social', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Segundo Moran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Mexicano del Seguro Social'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asociado B', 'investigatorFullName': 'Segundo Moran Villota', 'investigatorAffiliation': 'Coordinación de Investigación en Salud, Mexico'}}}}