Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-05 @ 6:03 PM
Study NCT ID:
NCT05526404
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of daily stool goal', 'timeFrame': '4 weeks', 'description': 'Number of subject to achieve daily stool goal, determined if use of the mobile application leads to improved rates of meeting daily stool goal (3-4 stools per day of Bristol Stool Scale 3-4)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to assess the safety and efficacy of using mobile application-based Bristol stool scale to titrate lactulose in prevention episodes of hepatic encephalopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written, informed consent.\n* Currently taking lactulose daily for prevention of hepatic encephalopathy.\n\nExclusion Criteria:\n\n* Recent change in dosing of opioid medication.\n* Previous Colorectal Surgery.\n* Active diarrheal illness.\n* Lack of smartphone or other smart device at home.'}, 'identificationModule': {'nctId': 'NCT05526404', 'briefTitle': 'Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy', 'orgStudyIdInfo': {'id': '22-006646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile application-based Bristol stool scale', 'description': 'Subjects with cirrhosis who are taking lactulose for the treatment of hepatic encephalopathy will download the Dieta mobile application on their mobile device and take a photo of each bowel movement using the Dieta application', 'interventionNames': ['Other: Dieta mobile application']}], 'interventions': [{'name': 'Dieta mobile application', 'type': 'OTHER', 'description': 'Mobile application that functions on mobile phones and allows for tracking of symptoms, dietary intake, and stool characteristics using logs and pictures. Users of the application track symptoms by completing questionnaires regarding stool frequency, consistency, and mental status changes. Users can track dietary intake and stool characteristics by taking time-stamped photos of all dietary intake and bowel movements.', 'armGroupLabels': ['Mobile application-based Bristol stool scale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Douglas Simonetto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Douglas (Doug) A. Simonetto', 'investigatorAffiliation': 'Mayo Clinic'}}}}