Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-30 @ 4:21 PM
Study NCT ID:
NCT04894656
Status:
WITHDRAWN
Last Update Posted:
2023-04-19
First Post:
2021-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intestinal Permeability and Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016482', 'term': 'Urinalysis'}, {'id': 'D005773', 'term': 'Gastroscopy'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study withdrawn due to funding.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.', 'timeFrame': 'through study completion, approximately 3-4 days'}], 'secondaryOutcomes': [{'measure': 'Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.', 'timeFrame': 'through study completion, approximately 3-4 days'}, {'measure': 'Measure serum levels of immune markers (e.g., IL-1,4,6,10,12,13,18; zonulin, CRP, TNF-alpha, tryptase,) in GP patients and compare to healthy controls.', 'timeFrame': 'One time measurement'}, {'measure': 'Quantitate different duodenal cell types (e.g., mast cells (CK117), eosinophils, enterochromaffin, intraepithelial lymphocytes (IELs) and CCK-containing cells) in patients with GP using biopsies from both the D1 and D2 duodenal segments.', 'timeFrame': 'through study completion, approximately 3-4 days'}, {'measure': 'Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.', 'timeFrame': 'through study completion, approximately 3-4 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroparesis', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18-75 years old).\n* Men and women.\n* Patients with gastroparesis.\n\nExclusion Criteria:\n\n* Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), GERD, esophagitis, eosinophilic esophagitis or H. pylori.\n* Patients with uncontrolled diabetes mellitus (hemoglobin A1C \\> 10).\n* Patients with prior surgery to the esophagus, stomach or duodenum.\n* Patients taking opioids, steroids, anti-histamines, immunosuppressive agents, NSAIDs, or mast cell stabilizing agents within the prior 3 months.\n* Patients currently prescribed aspirin or aspirin regimens for other clinical reasons.\n* Patients with known allergies to lactulose: mannitol will be excluded.'}, 'identificationModule': {'nctId': 'NCT04894656', 'briefTitle': 'Intestinal Permeability and Gastroparesis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis', 'orgStudyIdInfo': {'id': '21-000771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastroparesis patients', 'interventionNames': ['Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteers', 'interventionNames': ['Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy']}], 'interventions': [{'name': 'Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Tests to assess intestinal permeability', 'armGroupLabels': ['Gastroparesis patients', 'Healthy volunteers']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Cangemi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David J. Cangemi', 'investigatorAffiliation': 'Mayo Clinic'}}}}