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

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.

Study Overview

• Status: Completed
• Conditions: Spondyloarthropathies
• Intervention / Treatment: Procedure: Capsule endoscopy examination; Procedure: Colonoscopy

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.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 020125
    • Gastroenterology Department, Colentina Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spondyloarthropathies; 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; Examination of the small bowel with endoscopic videocapsule; Other Names: Given imaging capsule SB2; Procedure: Colonoscopy; Endoscopic examination of the large bowel and terminal ileum; Other Names: Olympus Evis Exera II videocolonoscope

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carol Davila University of Medicine and Pharmacy
• Collaborators: Clinical Hospital Colentina; EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH
• Investigators: Principal Investigator: Mihail R Voiosu, M.D., Ph.D., Carol Davila University of Medicine and Pharmacy; Study Chair: Mihai Rimbas, M.D., Carol Davila University of Medicine and Pharmacy

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 7, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Nonsteroidal anti-inflammatory drugs; Seronegative spondyloarthropathies; Endoscopic capsule examination; Small bowel and colon lesions; Anti TNF Alpha Drugs
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Spondylarthropathies
• Other Study ID Numbers: UMFCD-Idei-320/2007; Idei-320/01-10-2007