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

This study has been completed.
Sponsor:
Collaborators:
EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH
Clinical Hospital Colentina
Information provided by (Responsible Party):
Prof. Dr. Mihail Radu Voiosu, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT00768950
First received: October 7, 2008
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Spondyloarthropathies
Procedure: Capsule endoscopy examination
Procedure: Colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides

Resource links provided by NLM:


Further study details as provided by Carol Davila University of Medicine and Pharmacy:

Primary Outcome Measures:
  • Number of patients with bowel lesions [ Time Frame: July 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of the bowel lesions with patient status [ Time Frame: July 2012 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Given imaging capsule SB2
Procedure: Colonoscopy
Endoscopic examination of the large bowel and terminal ileum
Other Name: Olympus Evis Exera II videocolonoscope

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768950

Locations
Romania
Gastroenterology Department, Colentina Clinical Hospital
Bucharest, Romania, 020125
Sponsors and Collaborators
Carol Davila University of Medicine and Pharmacy
EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH
Clinical Hospital Colentina
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
  More Information

Publications:
Responsible Party: Prof. Dr. Mihail Radu Voiosu, University Professor, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT00768950     History of Changes
Other Study ID Numbers: UMFCD-Idei-320/2007, Idei-320/01-10-2007
Study First Received: October 7, 2008
Last Updated: August 13, 2013
Health Authority: Romania: Ministry of Education and Research

Keywords provided by Carol Davila University of Medicine and Pharmacy:
Seronegative spondyloarthropathies
Endoscopic capsule examination
Small bowel and colon lesions
Nonsteroidal anti-inflammatory drugs
Anti TNF Alpha Drugs

Additional relevant MeSH terms:
Spondylarthritis
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014