Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-27 @ 1:50 PM
Study NCT ID:
NCT05070351
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2021-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-29', 'size': 999260, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-24T15:35', 'hasProtocol': True}, {'date': '2021-09-20', 'size': 152950, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-24T15:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in gastrointestinal tract microbiome', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Pre-TIPS to post-TIPS change in stool taxon abundances as measured by 16S rRNA sequencing'}], 'primaryOutcomes': [{'measure': 'Minimal hepatic encephalopathy', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score'}], 'secondaryOutcomes': [{'measure': 'Per-protocol evaluation of minimal hepatic encephalopathy', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score, based on actual reported PPI use'}, {'measure': 'Chronic liver disease specific quality of life', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Chronic liver disease (CLDQ) specific QOL assessment'}, {'measure': 'Gastroesophageal reflux specific quality of life', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Gastroesophageal reflux (QOLRAD) specific QOL assessment'}, {'measure': 'Overt hepatic encephalopathy', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Episodes of overt hepatic encephalopathy (defined as West-Haven grade 2 or greater)'}, {'measure': 'On-demand requirement for acid suppression therapy', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Proportion of patients in the PPI discontinuation arm needing on-demand H2 blockers or PPIs for gastroesophageal reflux symptoms'}, {'measure': 'Adverse events', 'timeFrame': 'Approximately 6-8 weeks', 'description': 'Adverse events in the PPI continuation versus discontinuation arms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy']}, 'descriptionModule': {'briefSummary': 'A total of 40 patients taking proton pump inhibitors (PPIs) who undergo transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized in 1:1 fashion to either continue or discontinue their PPIs to determine whether these commonly used gastric acid suppressing agents increase risk of post-TIPS hepatic encephalopathy (HE). Patients will be assessed for symptoms of minimal HE (MHE), using the established psychometric hepatic encephalopathy score (PHES) battery of tests. MHE assessment will be conducted at two timepoints: at baseline prior to randomization and TIPS creation and approximately 4 weeks after randomization and TIPS creation. Stool samples will also be collected at both timepoints to allow characterization of the gastrointestinal (GI) tract microbiome using 16S rRNA sequencing. The pre to post-TIPS change in PHES scores will be compared between patients randomized to continue versus discontinue their PPIs. Quality of life (QOL) will also be assessed. Changes in the GI tract microbiome will be analyzed to determine whether this represents a potential biological mechanism linking PPI use with post-TIPS HE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing TIPS creation as part of routine clinical care\n* On PPIs therapy (at least 20 mg omeprazole equivalent daily)\n* Provision of signed and dated informed consent form by participant or legal representative\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, age greater or equal to 18\n\nExclusion Criteria:\n\n* Grade IV esophagitis or gastric or duodenal ulcer\n* Recent endoscopic esophageal variceal band ligation necessitating PPI therapy for prevention of banding ulcer\n* Zollinger-Ellison syndrome\n* Active Helicobacter pylori infection\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05070351', 'briefTitle': 'Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Randomized Open-label Trial of Deprescribing Proton Pump Inhibitors to Reduce the Risk of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Creation', 'orgStudyIdInfo': {'id': 'Pro00108517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPI deprescribing arm', 'description': 'Patients taking a PPI (at least 20 mg omeprazole equivalent daily) will be instructed to stop taking their PPI.', 'interventionNames': ['Drug: PPI deprescribing']}, {'type': 'NO_INTERVENTION', 'label': 'PPI continuation arm', 'description': 'Patients will be instructed to continue taking their PPI (at least 20 mg omeprazole equivalent daily) as usual.'}], 'interventions': [{'name': 'PPI deprescribing', 'type': 'DRUG', 'description': 'Patients currently on a proton pump inhibitor (PPI) undergoing transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized to receive instructions to stop taking their PPI.', 'armGroupLabels': ['PPI deprescribing arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'James Ronald, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}