Clinical trial NCT00768950: The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
Official title: The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthropathies
Keywords: Seronegative spondyloarthropathies
Endoscopic capsule examination
Small bowel and colon lesions
Nonsteroidal anti-inflammatory drugs
Anti TNF Alpha Drugs
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH
name: Clinical Hospital Colentina
First posted: 2008-10-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) reffered to a Universitary Clinic of Internal Medicine and Rheumatology

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with bowel lesions
timeFrame: July 2012
Secondary outcomes:
measure: Correlation of the bowel lesions with patient status
timeFrame: July 2012
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Gastroenterology Department, Colentina Clinical Hospital
Study officials:
affiliation: Carol Davila University of Medicine and Pharmacy
name: Mihail R Voiosu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carol Davila University of Medicine and Pharmacy
name: Mihai Rimbas, M.D.
role: STUDY_CHAIR
References:
citation: Rimbas M, Marinescu M, Voiosu MR. Bowel lesions in spondyloarthritides. Rom J Intern Med. 2009;47(1):75-85.
citation: 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.
citation: 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.