The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
NCT ID: NCT00768950
Last Updated: 2013-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65 participants
OBSERVATIONAL
2008-01-31
2013-08-31
Brief Summary
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It 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.
Detailed Description
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Up 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.
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.
On the other hand, biologics used to treat patients with SA are believed to favorably influence the small bowel lesions that are concomitantly present.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature.
The 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.
Our 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.
Thus, we hope to identify the therapeutic strategies that are most suited in the management of these patients.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Spondyloarthropathies
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
Capsule endoscopy examination
Examination of the small bowel with endoscopic videocapsule
Colonoscopy
Endoscopic examination of the large bowel and terminal ileum
Interventions
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Capsule endoscopy examination
Examination of the small bowel with endoscopic videocapsule
Colonoscopy
Endoscopic examination of the large bowel and terminal ileum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* subjects 18 years old or more
* patients with spondyloarthropathy as defined by the Amor criteria
Exclusion Criteria
* impaired deglutition
* cardiac pace-makers present
* pregnancy
* pelvic or abdominal radiotherapy anytime in the past
* major abdominal surgery anytime in the past
* major comorbidities which could represent a contraindication to a surgical abdominal intervention
18 Years
ALL
No
Sponsors
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EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH
UNKNOWN
Clinical Hospital Colentina
OTHER
Carol Davila University of Medicine and Pharmacy
OTHER
Responsible Party
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Prof. Dr. Mihail Radu Voiosu
University Professor
Principal Investigators
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Mihail R Voiosu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Carol Davila University of Medicine and Pharmacy
Mihai Rimbas, M.D.
Role: STUDY_CHAIR
Carol Davila University of Medicine and Pharmacy
Locations
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Gastroenterology Department, Colentina Clinical Hospital
Bucharest, , Romania
Countries
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References
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Rimbas M, Marinescu M, Voiosu MR. Bowel lesions in spondyloarthritides. Rom J Intern Med. 2009;47(1):75-85.
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.
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.
Other Identifiers
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Idei-320/01-10-2007
Identifier Type: -
Identifier Source: secondary_id
UMFCD-Idei-320/2007
Identifier Type: -
Identifier Source: org_study_id