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Behçet's Disease and Eosinophil Cationic Protein

Sponsor
Cukurova University (Other)
Overall Status
Completed
CT.gov ID
NCT01584778
Collaborator
(none)
47
Enrollment
1
Location
11
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Eosinophil cationic protein (ECP) is a matrix protein of eosinophils and has been reported to reflect eosinophil activity. Few studies have examined the role of eosinophils in the pathogenesis of Behçet's disease. The purpose of the present study is to investigate the serum ECP levels in BD and its relation to clinical activity.

Condition or Disease Intervention/Treatment Phase
  • Other: eosinophil cationic protein

Detailed Description

Behçet's disease (BD) is a systemic vasculitis, characterized by recurrent oral aphthae, genital ulcers, uveitis, skin lesions, arthritis, gastrointestinal and neurologic manifestations. There has been a growing interest in research on the pathogenesis of the disease. Eosinophils has been implicated in the vascular injury associated with several vasculitis syndromes like Churg Strauss syndrome, temporal arteritis and Henoch-Schonlein purpura. In Behçet patients, serum IgE and eosinophils have been reported to be comparable with the controls but eosinophil activity has not been studied extensively. Eosinophil cationic protein (ECP) is a matrix protein of specific granules of eosinophils with considerable capacity to damage tissue and cells and has been reported to reflect eosinophil activity. Increased serum levels of ECP has been reported in patients with seasonal allergic rhinitis. Several immunomodulatory features of ECP has been reported, such as inhibition of the proliferative T-lymphocyte response to antigen, immunoglobulin production, proliferation of plasma cell lines and upregulation of ICAM-1. Procoagulant effects of ECP has also been reported. The present study was conducted in patients without usage of any confounding drugs that can effect serum ECP levels. The purpose of this study was to investigate the serum ECP levels in BD and its relation to the clinical activity.

Forty-seven consecutive patients with BD (22 active, 25 inactive) meeting International Study Group Criteria , 21 age and sex matched patients with allergic rhinitis and 21 apparently healthy controls were evaluated prospectively in Rheumatology-Immunology Outpatient Clinic. Clinical activity was defined according to the criteria proposed by "Behcet's Disease Research Committee of Japan" . Activity scoring was made according to the "Behçet's Disease Research Committee of Japan" which was proposed in 1994. Organ involvements of the patients were summarized.

Patients on corticosteroids or immunosuppressives were excluded. Colchicine was stopped 10 days prior to the blood collection in inactive patients. Blood was drawn from the active patients before starting treatment. Cases with any allergy history or parasitosis were excluded.

Study Design

Study Type:
Observational
Actual Enrollment :
47 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Serum Eosinophil Cationic Protein Levels in Behçet's Disease and Its Relation to the Clinical Activity
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Dec 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Behçet patients

Other: eosinophil cationic protein
Serum eosinophil cationic protein levels
Other Names:
  • ECP

    		•
    Healthy controls

    Other: eosinophil cationic protein
    Serum eosinophil cationic protein levels
    Other Names:
  • ECP

    		•
    Allergic rhinitis (diseased) controls

    Other: eosinophil cationic protein
    Serum eosinophil cationic protein levels
    Other Names:
  • ECP

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      16 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Consecutive Behçet patients who gave the written informed consent were included.
      Exclusion Criteria:
      • Patients on corticosteroids or immunosuppressives were excluded.Cases with any allergy history or parasitosis were excluded.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department Adana Turkey 01330

      Sponsors and Collaborators

      • Cukurova University

      Investigators

      • Study Chair: Hüseyin TE Ozer, Assoc. Prof., Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department
      • Study Director: Eren Erken, Prof. Dr., Cukurova University, Faculty of Medicine, Rheumatology-Immunology Department

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Didem Arslan Tas, Dr. Didem Arslan Tas, Cukurova University
      ClinicalTrials.gov Identifier:
      NCT01584778
      Other Study ID Numbers:
      • TF.00.U.32.
      First Posted:
      Apr 25, 2012
      Last Update Posted:
      Apr 26, 2012
      Last Verified:
      Apr 1, 2012
      Keywords provided by Didem Arslan Tas, Dr. Didem Arslan Tas, Cukurova University
      Behçet's disease
      Eosinophil cationic protein
      Eosinophils
      Additional relevant MeSH terms:
      Behcet Syndrome
      Eosinophil Cationic Protein

      Study Results

      No Results Posted as of Apr 26, 2012