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Completed

NCT Number: NCT00768950

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology Department, Colentina Clinical Hospital

Bucharest, 020125, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsule endoscopy examination

Procedure

Examination of the small bowel with endoscopic videocapsule

Other names: Given imaging capsule SB2

colonoscopy

Procedure

Endoscopic examination of the large bowel and terminal ileum

Other names: Olympus Evis Exera II videocolonoscope

Primary outcomes

  1. Number of patients with bowel lesions

    Time frame: July 2012

Secondary outcomes

  1. Correlation of the bowel lesions with patient status

    Time frame: July 2012

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Collaborators

  • Clinical Hospital Colentina
  • EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH

Registry information

Acronym: SPONDILENDO

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2008
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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