Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT00811434
Status:
TERMINATED
Last Update Posted:
2014-02-10
First Post:
2008-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Lactulose in Children With Chronic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007792', 'term': 'Lactulose'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gsrao@iupui.edu', 'phone': '317-944-3774', 'title': 'Girish Subbarao', 'organization': 'Riley Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Total of 23 months', 'description': 'Assessed at both in person patient visits and phone call follow up', 'eventGroups': [{'id': 'EG000', 'title': 'Lactulose', 'description': '3 months of Lactulose therapy based on pt. weight', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '1.5 ml/kg day po of sugar water placebo for three months', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Randomized Participants'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'failure of one cognitive function test indicates presence of MHE', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Randomized Participants'}], 'timeFrame': 'baseline', 'description': 'HRQOL administered to parents prior to treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected as planned'}, {'type': 'SECONDARY', 'title': 'Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactulose', 'description': '3 months of Lactulose therapy based on pt. weight'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1.5 ml/kg day po of sugar water placebo for three months'}], 'timeFrame': 'before and after each treatment period', 'description': 'MHE as measured by failure of one or more cognitive test', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected as planned'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactulose First, Then Placebo', 'description': 'Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day'}, {'id': 'FG001', 'title': 'Placebo First, Then Lactulose', 'description': 'Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (1 Month)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Informed consent was obtained on the first subject 1/16/2009 and recruitment continued until study closure in November 2010.', 'preAssignmentDetails': 'Two subjects were withdrawn prior to randomization.Two did not meet entry criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'all aprticipants who were randomized to receive treatment'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'funding period ended', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-07', 'studyFirstSubmitDate': '2008-12-18', 'resultsFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2008-12-18', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-07', 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis', 'timeFrame': 'baseline', 'description': 'failure of one cognitive function test indicates presence of MHE'}], 'secondaryOutcomes': [{'measure': 'Health Related Quality of Life (HRQOL)', 'timeFrame': 'baseline', 'description': 'HRQOL administered to parents prior to treatment'}, {'measure': 'Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function', 'timeFrame': 'before and after each treatment period', 'description': 'MHE as measured by failure of one or more cognitive test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['encephalopathy', 'pediatric liver disease', 'pediatric cirrhosis', 'serum ammonia levels'], 'conditions': ['Minimal Hepatic Encephalopathy']}, 'descriptionModule': {'briefSummary': 'Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.', 'detailedDescription': 'In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy\n\nExclusion Criteria:\n\n* patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.\n* patients with known hearing or vision difficulties.\n* those patients who do not speak English will be excluded.'}, 'identificationModule': {'nctId': 'NCT00811434', 'acronym': 'MHE', 'briefTitle': 'Study of Lactulose in Children With Chronic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease', 'orgStudyIdInfo': {'id': '0808-19'}, 'secondaryIdInfos': [{'id': 'Clarian Grant VFR-279'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lactulose', 'description': '3 months of Lactulose therapy based on pt. weight', 'interventionNames': ['Drug: Lactulose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '1.5 ml/kg day po of sugar water placebo for three months', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Lactulose', 'type': 'DRUG', 'description': '1.5cc/kg/day po for three months', 'armGroupLabels': ['Lactulose']}, {'name': 'placebo', 'type': 'DRUG', 'description': '1.5 ml sugar water/kg day for three months', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'James Whitcomb Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Girish Subbarao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}