Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Other: Biopsy and blood sampling; Other: Blood sampling and biopsy

• Registration Number: NCT00769236
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

We propose to study the intestinal secretion of ASCA by evaluating them in biopsy culture supernatants from a cohort of patients suffering from CD (n=80) and a cohort of control patients (UC (n=40) and patients without IBD (n=40 )).

Detailed Description

Its diagnosis is based upon clinical, endoscopic and histological parameters but recent studies have shown that seric evaluation of immunological markers (anti-Saccharomyces cerevisiae antibodies (ASCA), anti-neutrophil cytoplasmic auti-antibodies (ANCA)) could be useful. Crohn's disease (CD) is an inflammatory bowel disease (IBD) of the young people. Antibodies anti-chitobisoside carbohydrate (ACCA), anti-laminaribioside carbohydrate (ALCA) and anti-mannobioside carbohydrate (AMCA) have been described as new serological markers of CD.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients reached by disease of crohn
• patients reached by hemorrhagic first side-colitis

Exclusion Criteria

• Forms ileales or ano-périneales pure of disease of crohn
• indefinite colitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Biopsy and blood sampling	Patients reached by hemorrhagic first side-colitis
1	Blood sampling and biopsy	Patients with crohn disease
3	Biopsy and blood sampling	Patients controls

Primary Outcome Measures

Name	Time	Method
Compare the performances of the dosage of the ASCA in floating it of culture of intestinal biopsies in that of their dosage in the serum	24 months

Secondary Outcome Measures

Name	Time	Method
Determine if the patients reached by disease of crohn not presenting ASCA in their serum represent one under group of disease of crohn	24 months

Trial Locations

Locations (1)

Laboratoire d'Immunologie - Hopital de la Conception; 🇫🇷 Marseille, France