The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides

Study Overview
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Brief Summary
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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. 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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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). 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.

Official Title
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The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides

Conditions
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Spondyloarthropathies

Intervention / Treatment
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* Procedure: Capsule endoscopy examination
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signing of the inform consent subjects 18 years old or more patients with spondyloarthropathy as defined by the Amor criteria Exclusion Criteria: presumed intestinal obstruction 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spondyloarthropathies<br>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 | Procedure: Capsule endoscopy examination<br>* Examination of the small bowel with endoscopic videocapsule<br>* Other names: Given imaging capsule SB2;Procedure: Colonoscopy<br>* Endoscopic examination of the large bowel and terminal ileum<br>* Other names: Olympus Evis Exera II videocolonoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bowel lesions |  | July 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the bowel lesions with patient status |  | July 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seronegative spondyloarthropathies, Endoscopic capsule examination, Small bowel and colon lesions, Nonsteroidal anti-inflammatory drugs, Anti TNF Alpha Drugs