Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT01405105
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2011-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exacerbating Factors in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-13', 'studyFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of identifiable trigger for flare', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ulcerative Colitis', "Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.", 'detailedDescription': 'Detailed questionnaires with patient in regards to potential triggers for flares of IBD. Includes both patients with flares and those in remission as a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Flare of Crohn's disease Flare of ulcerative colitis Quiescent IBD (control)", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of verified Crohn's disease or ulcerative colitis\n\nExclusion Criteria:\n\n* unwilling to participate"}, 'identificationModule': {'nctId': 'NCT01405105', 'briefTitle': 'Exacerbating Factors in Inflammatory Bowel Disease', 'organization': {'class': 'FED', 'fullName': 'Dallas VA Medical Center'}, 'officialTitle': 'Exacerbating Factors in Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'DVAMC-09-010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Flares of IBD', 'description': "Active flare of Crohn's or UC"}, {'label': 'Control Group', 'description': "Patients with quiescent Crohn's disease or UC"}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Linda A Feagins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dallas VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dallas VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Centocor Ortho Biotech Services, L.L.C.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Gastroenterologist', 'investigatorFullName': 'Linda A Feagins', 'investigatorAffiliation': 'Dallas VA Medical Center'}}}}