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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00768950
Acronym
SPONDILENDO
Enrollment
65
Registered
2008-10-08
Start date
2008-01-31
Completion date
2013-08-31
Last updated
2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthropathies

Keywords

Seronegative spondyloarthropathies, Endoscopic capsule examination, Small bowel and colon lesions, Nonsteroidal anti-inflammatory drugs, Anti TNF Alpha Drugs

Brief summary

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

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.

Interventions

PROCEDURECapsule endoscopy examination

Examination of the small bowel with endoscopic videocapsule

PROCEDUREColonoscopy

Endoscopic examination of the large bowel and terminal ileum

Sponsors

EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH
CollaboratorUNKNOWN
Clinical Hospital Colentina
CollaboratorOTHER
Carol Davila University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients with bowel lesionsJuly 2012

Secondary

MeasureTime frame
Correlation of the bowel lesions with patient statusJuly 2012

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026