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

Spondyloarthropathies Clinical Trial

— SPONDILENDO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768950
• Other study ID #: UMFCD-Idei-320/2007
• Secondary ID: Idei-320/01-10-2
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: August 13, 2013
• Start date: January 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Education and Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylarthropathies
• Spondyloarthropathies

Intervention

Procedure:
• Capsule endoscopy examination
Examination of the small bowel with endoscopic videocapsule
• Colonoscopy
Endoscopic examination of the large bowel and terminal ileum

Locations

Country	Name	City	State
Romania	Gastroenterology Department, Colentina Clinical Hospital	Bucharest

Sponsors (3)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy	Clinical Hospital Colentina, EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH

Country where clinical trial is conducted

Romania, 

References & Publications (2)

Rimbas M, Marinescu M, Voiosu MR, Baicus CR, Caraiola S, Nicolau A, Nitescu D, Badea GC, Pârvu MI. NSAID-induced deleterious effects on the proximal and mid small bowel in seronegative spondyloarthropathy patients. World J Gastroenterol. 2011 Feb 28;17(8) — View Citation

Rimbas M, Marinescu M, Voiosu MR. Bowel lesions in spondyloarthritides. Rom J Intern Med. 2009;47(1):75-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with bowel lesions		July 2012	No
Secondary	Correlation of the bowel lesions with patient status		July 2012	No