Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT03529318
Status:
WITHDRAWN
Last Update Posted:
2019-10-22
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mucosal Innate Immune Activation in Chronic Intestinal Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-07', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of specimens showing elevated levels of mucosal innate immune activation', 'timeFrame': 'Up to 2 years', 'description': 'Determining the level of mucosal innate immune activation by staining, organoid culture, Western blot analysis, and cytokine expression on biopsy samples in IBD and IBS patient samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': "Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The subject population includes patients with known Crohn's disease, ulcerative colitis and indeterminant colitis. Patients will be recruited after they check in to the endoscopy unit, and before their endoscopic procedure, prior to any pre-procedure sedation medications having been given. All participants are undergoing endoscopy with biopsy for surveillance, screening, , diagnosis , or assessment of treatment. If no biopsy specimens are taken from subjects for diagnosis, no biopsy samples are taken for research purposes. The subject enrollment goal is 60 separate subjects with Crohn's disease, ulcerative colitis and indeterminant colitis or Irritable bowel syndrome. The subjects' participation will be limited to in the endoscopy suite.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, 18-years old and older\n* Presenting at the University of Arkansas for Medical Sciences (UAMS) Endoscopy center to undergo endoscopy with biopsy for surveillance, screening or diagnosis.\n\nExclusion Criteria:\n\n* Subjects classified in an anesthesia risk group , American Society of Anesthesiologists Class (ASA) ≥ 4,\n* history of bleeding diathesis or coagulopathy\n* stroke or transient neurological attack within the last 6 months\n* pregnancy\n* currently on blood thinners (excepting aspirin)\n* subject is unable to consent themselves'}, 'identificationModule': {'nctId': 'NCT03529318', 'briefTitle': 'Mucosal Innate Immune Activation in Chronic Intestinal Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Mucosal Innate Immune Activation in Chronic Intestinal Disorders', 'orgStudyIdInfo': {'id': '217718'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biopsies from endoscopy', 'type': 'PROCEDURE', 'description': '1\\) Patients scheduled for endoscopy (EGD or colonoscopy) for IBD will be consented to allow physicians who are performing endoscopies to take additional biopsies and blood samples for "research purposes".'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Benjamin Tharian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}, {'name': 'Julia Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}