Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-01 @ 2:58 AM
Study NCT ID:
NCT00768950
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2008-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025242', 'term': 'Spondylarthropathies'}], 'ancestors': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-13', 'studyFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with bowel lesions', 'timeFrame': 'July 2012'}], 'secondaryOutcomes': [{'measure': 'Correlation of the bowel lesions with patient status', 'timeFrame': 'July 2012'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Seronegative spondyloarthropathies', 'Endoscopic capsule examination', 'Small bowel and colon lesions', 'Nonsteroidal anti-inflammatory drugs', 'Anti TNF Alpha Drugs'], 'conditions': ['Spondyloarthropathies']}, 'referencesModule': {'references': [{'pmid': '19886073', 'type': 'BACKGROUND', 'citation': 'Rimbas M, Marinescu M, Voiosu MR. Bowel lesions in spondyloarthritides. Rom J Intern Med. 2009;47(1):75-85.'}, {'pmid': '21448355', 'type': 'RESULT', 'citation': 'Rimbas M, Marinescu M, Voiosu MR, Baicus CR, Caraiola S, Nicolau A, Nitescu D, Badea GC, Parvu MI. NSAID-induced deleterious effects on the proximal and mid small bowel in seronegative spondyloarthropathy patients. World J Gastroenterol. 2011 Feb 28;17(8):1030-5. doi: 10.3748/wjg.v17.i8.1030.'}, {'pmid': '28103201', 'type': 'DERIVED', 'citation': 'Chitul A, Voiosu AM, Marinescu M, Caraiola S, Nicolau A, Badea GC, Parvu MI, Ionescu RA, Mateescu BR, Voiosu MR, Baicus CR, Rimbas M. Different effects of anti-TNF-alpha biologic drugs on the small bowel macroscopic inflammation in patients with ankylosing spondylitis. Rom J Intern Med. 2017 Mar 1;55(1):44-52. doi: 10.1515/rjim-2017-0001.'}]}, 'descriptionModule': {'briefSummary': 'Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop. Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.\n\nIt is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature, especially regarding small bowel lesions.', 'detailedDescription': 'The Seronegative Spondyloarthritides (SA) are a group of disorders that share certain clinical features and an association with the hla-b27 allele, having also overlapping features with inflammatory bowel disease (IBD).\n\nUp to 60% of patients have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop.\n\nLesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.\n\nOn the other hand, biologics used to treat patients with SA are believed to favorably influence the small bowel lesions that are concomitantly present.\n\nIt is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature.\n\nThe design of the proposed study involves performing one full colonoscopic examination (including ileoscopy) followed by one capsule endoscopy examination to the patients with SA. Prior to these examination, the patency of the gi tract will be tested using a patency capsule. If the patency of the gi tract is not confirmed, then the capsule endoscopy examination is abandoned.\n\nOur aim is to explore about 100 patients in three years, thus having a close-to-reality "look" into the presence and extent of bowel involvement in the pool of the patients having SA; and also to characterize the lesions mainly depending on the treatment received, concomitant pathology and the form of the disease. We also aim to identify a relationship between the lesions found at colonoscopy and capsule endoscopy, the purpose being the possibility to predict one having only performed the other.\n\nThus, we hope to identify the therapeutic strategies that are most suited in the management of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) reffered to a Universitary Clinic of Internal Medicine and Rheumatology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signing of the inform consent\n* subjects 18 years old or more\n* patients with spondyloarthropathy as defined by the Amor criteria\n\nExclusion Criteria:\n\n* presumed intestinal obstruction\n* impaired deglutition\n* cardiac pace-makers present\n* pregnancy\n* pelvic or abdominal radiotherapy anytime in the past\n* major abdominal surgery anytime in the past\n* major comorbidities which could represent a contraindication to a surgical abdominal intervention'}, 'identificationModule': {'nctId': 'NCT00768950', 'acronym': 'SPONDILENDO', 'briefTitle': 'The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides', 'organization': {'class': 'OTHER', 'fullName': 'Carol Davila University of Medicine and Pharmacy'}, 'officialTitle': 'The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides', 'orgStudyIdInfo': {'id': 'UMFCD-Idei-320/2007'}, 'secondaryIdInfos': [{'id': 'Idei-320/01-10-2007'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spondyloarthropathies', 'description': 'Patients with spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) as defined by the AMOR criteria', 'interventionNames': ['Procedure: Capsule endoscopy examination', 'Procedure: Colonoscopy']}], 'interventions': [{'name': 'Capsule endoscopy examination', 'type': 'PROCEDURE', 'otherNames': ['Given imaging capsule SB2'], 'description': 'Examination of the small bowel with endoscopic videocapsule', 'armGroupLabels': ['Spondyloarthropathies']}, {'name': 'Colonoscopy', 'type': 'PROCEDURE', 'otherNames': ['Olympus Evis Exera II videocolonoscope'], 'description': 'Endoscopic examination of the large bowel and terminal ileum', 'armGroupLabels': ['Spondyloarthropathies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '020125', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Gastroenterology Department, Colentina Clinical Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Mihail R Voiosu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carol Davila University of Medicine and Pharmacy'}, {'name': 'Mihai Rimbas, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Carol Davila University of Medicine and Pharmacy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carol Davila University of Medicine and Pharmacy', 'class': 'OTHER'}, 'collaborators': [{'name': 'EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH', 'class': 'UNKNOWN'}, {'name': 'Clinical Hospital Colentina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University Professor', 'investigatorFullName': 'Prof. Dr. Mihail Radu Voiosu', 'investigatorAffiliation': 'Carol Davila University of Medicine and Pharmacy'}}}}