Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT02303132
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046728', 'term': 'Colitis, Microscopic'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Transepithelial electircal resistance', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Change in permeation of a fluorescent marker', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Microscopic Colitis']}, 'descriptionModule': {'briefSummary': 'Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a local immune response. MC patients are considered to be susceptible hosts, prone to react on administration of abovementioned drugs. In order to test this hypothesis and to generate new insights in the pathophysiology of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)\n* Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion\n\nExclusion Criteria:\n\n* Age below 18 years at the time of diagnosis\n* Use of anticoagulants or immunosuppressive drugs\n* Severe co-morbidities hindering an endoscopic procedure\n* A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy\n* A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.\n* Use of medication known to influence intestinal permeability\n* Excessive alcohol usage (\\>20 standard units per week)\n* Not capable of signing an informed consent'}, 'identificationModule': {'nctId': 'NCT02303132', 'briefTitle': 'Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis', 'orgStudyIdInfo': {'id': 'NL48505.068.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active MC', 'description': 'Patients with active MC will be included', 'interventionNames': ['Other: Ussing experiment']}, {'type': 'OTHER', 'label': 'MC in remission', 'description': 'Patients with MC in remission will be included', 'interventionNames': ['Other: Ussing experiment']}, {'type': 'OTHER', 'label': 'Controls', 'description': 'Patients without MC will be included', 'interventionNames': ['Other: Ussing experiment']}], 'interventions': [{'name': 'Ussing experiment', 'type': 'OTHER', 'description': 'fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.', 'armGroupLabels': ['Active MC', 'Controls', 'MC in remission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'A Masclee, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}