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

NCT00768950 | Completed DMC

• 2 other identifiers: UMFCD-Idei-320/2007Idei-320/01-10-2007
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthropathies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with bowel lesions

  July 2012

Secondary Outcomes (1)

• Correlation of the bowel lesions with patient status

  July 2012

Study Arms (1)

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; Procedure: Colonoscopy

Interventions

Capsule endoscopy examination PROCEDURE

Examination of the small bowel with endoscopic videocapsule

Also known as: Given imaging capsule SB2

Spondyloarthropathies

Colonoscopy PROCEDURE

Endoscopic examination of the large bowel and terminal ileum

Also known as: Olympus Evis Exera II videocolonoscope

Spondyloarthropathies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• signing of the inform consent
• subjects 18 years old or more
• patients with spondyloarthropathy as defined by the Amor criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead
• EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH: collaborator
• Clinical Hospital Colentina: collaborator

Study Sites (1)

Gastroenterology Department, Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Related Publications (3)

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

  PMID: 19886073 BACKGROUND

• 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.

  PMID: 21448355 RESULT

• 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.

  PMID: 28103201 DERIVED

MeSH Terms

Conditions

Spondylarthropathies

Interventions

Infliximab; Colonoscopy

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mihail R Voiosu, M.D., Ph.D.

  Carol Davila University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

• Mihai Rimbas, M.D.

  Carol Davila University of Medicine and Pharmacy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

RO (1)