Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:14 AM
Study NCT ID:
NCT05061992
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Improve Quality of Life in People With Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'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'}]}, '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': 'etapper@med.umich.edu', 'phone': '734-647-9252', 'title': 'Dr. Elliot Tapper', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fall', 'notes': 'Non-injurious fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Complications from Liver Disease', 'notes': 'Hospitalizations occurred for participants because of complications with pre-existing liver disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Short Form-8 Health Survey (SF-8) at 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'classes': [{'title': 'Change in SF-8 from Baseline', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '12.4'}, {'value': '6.55', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '10.8'}]}]}, {'title': 'End of Trial SF-8', 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '77.9'}, {'value': '63.84', 'groupId': 'OG001', 'lowerLimit': '57.1', 'upperLimit': '70.6'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in SF-8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'End of trial SF-8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'The SF-8 is an abbreviated version of an original 36-item health survey (SF-36). It is a generic, multipurpose, quality of life instrument, containing psychometrically based physical and mental health summary measures. The eight domains are general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. Scores from the domains are combined and range from 0 (lowest quality of living) to 100 (highest quality of living).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Animal Naming Test (ANT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'classes': [{'title': 'Change in ANT', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.4'}, {'value': '-0.15', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '1.4'}]}]}, {'title': 'End of trial ANT', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '23.6'}, {'value': '18.52', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '20.8'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in ANT', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'End of trial ANT', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Number of unique animals named within 1 minute by the participant. Values below show the change from baseline and the results from the test taken 28 days later.', 'unitOfMeasure': 'Count of Animals Named', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Overall Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.3'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change between baseline (day 0) and 28 days', 'description': 'Overall sleep quality was measured on a 5-point Likert scale, with a range of 1 (very bad sleep quality) to 5 (very good sleep quality).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Regular Daily Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '4.0'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Single-question survey given to participants at baseline and again 28 days later. Participants ranked their daily activity impairment on a Likert scale of 0 (no impairment) to 10 (complete impairment)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants Who Fell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Bowel Movements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Results show the percentage of days in a 28-day span in which participants experienced more than 5 daily bowel movements. All participants analyzed in each arm were included in calculating the results using the following formula: (days with \\>5 bowel movements) / (patient-days in study) The results are presented as a single number because they are a point estimate of a population level proportion', 'unitOfMeasure': '% of participant-days with >5 bowels', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'FG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Excess bowel movements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Complications of Medical Care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Diarrhea Prior to Starting Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lactulose', 'description': 'Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.'}, {'id': 'BG001', 'title': 'No Treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Short Form-8 Health Survey (SF-8)', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '17.0', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '17.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '0 (lowest quality of living) to 100 (highest quality of living)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Animal Naming Test', 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '18.3', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '18.1', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of unique animals named within 1 minute by the participant.', 'unitOfMeasure': 'Count of Animals Named', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sleep Quality', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Overall sleep quality was measured on a 5-point Likert scale, with a range of 1 (very bad sleep quality) to 5 (very good sleep quality).', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Activity Impairment', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '5.6', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Single survey question where participants responded on a Likert scale of 0 (no impairment) to 10 (complete impairment)', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Participants Who Fell in Past 90 Days', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Yes or no question on whether participant had experienced at least 1 fall in the past 90 days.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 988930, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-13T08:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2021-09-20', 'resultsFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-17', 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Form-8 Health Survey (SF-8) at 28 Days', 'timeFrame': '28 days', 'description': 'The SF-8 is an abbreviated version of an original 36-item health survey (SF-36). It is a generic, multipurpose, quality of life instrument, containing psychometrically based physical and mental health summary measures. The eight domains are general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. Scores from the domains are combined and range from 0 (lowest quality of living) to 100 (highest quality of living).'}], 'secondaryOutcomes': [{'measure': 'Animal Naming Test (ANT)', 'timeFrame': '28 days', 'description': 'Number of unique animals named within 1 minute by the participant. Values below show the change from baseline and the results from the test taken 28 days later.'}, {'measure': 'Change in Overall Sleep Quality', 'timeFrame': 'Change between baseline (day 0) and 28 days', 'description': 'Overall sleep quality was measured on a 5-point Likert scale, with a range of 1 (very bad sleep quality) to 5 (very good sleep quality).'}, {'measure': 'Regular Daily Activity Impairment', 'timeFrame': '28 days', 'description': 'Single-question survey given to participants at baseline and again 28 days later. Participants ranked their daily activity impairment on a Likert scale of 0 (no impairment) to 10 (complete impairment)'}, {'measure': 'Participants Who Fell', 'timeFrame': '28 days', 'description': 'Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.'}, {'measure': 'Daily Bowel Movements', 'timeFrame': '28 days', 'description': 'Results show the percentage of days in a 28-day span in which participants experienced more than 5 daily bowel movements. All participants analyzed in each arm were included in calculating the results using the following formula: (days with \\>5 bowel movements) / (patient-days in study) The results are presented as a single number because they are a point estimate of a population level proportion'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic Encephalopathy', 'Liver Disease', 'Cirrhosis and portal hypertension'], 'conditions': ['Cirrhosis']}, 'descriptionModule': {'briefSummary': 'This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cirrhosis - must meet one of the following criteria:\n\n 1. liver biopsy, OR\n 2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR\n 3. 2 of the following 4 criteria:\n\n 1. Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)\n 2. Fibroscan liver stiffness score \\>13 Kilopascal (kPa)\n 3. Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) \\>2.0\n 4. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices\n\n Exclusion Criteria:\n* Non-English speaking\n* Pregnancy (self-reported)\n* Unable or unwilling to provide consent\n* History of liver transplant\n* Disorientation at the time of enrollment, Dementia, or Treated Memory Disorder\n* History of prior lactulose use or HE within 6 months\n* Metastatic solid malignancy or blood malignancy\n* Hemoglobin A1C \\> 12 (within past year)'}, 'identificationModule': {'nctId': 'NCT05061992', 'briefTitle': 'A Trial to Improve Quality of Life in People With Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial', 'orgStudyIdInfo': {'id': 'HUM00204056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactulose', 'interventionNames': ['Drug: Lactulose']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.'}], 'interventions': [{'name': 'Lactulose', 'type': 'DRUG', 'otherNames': ['Kristalose'], 'description': 'Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.\n\nIn addition, outcome measurements will be completed at baseline and day 28.', 'armGroupLabels': ['Lactulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Elliot Tapper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Internal Medicine', 'investigatorFullName': 'Elliot B. Tapper', 'investigatorAffiliation': 'University of Michigan'}}}}