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NCT00769236 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00769236
Other study ID # 2008-A00080-55
Secondary ID 2008-05
Status Completed
Phase N/A
First received October 8, 2008
Last updated August 27, 2014
Start date June 2008
Est. completion date August 2010

Study information
Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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 )).

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date August 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• Blood sampling and biopsy
Biopsy and blood : Research for various antibodies
• Biopsy and blood sampling
Biopsy and blood : research for various antibodies
• Biopsy and blood sampling
Blood and biopsy : research for various antibodies

Locations
Country Name City State
France Laboratoire d'Immunologie - Hopital de la Conception Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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