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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00769236
First received: October 8, 2008
Last updated: January 26, 2010
Last verified: January 2010
History of Changes
  Purpose

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 )).


Condition Intervention
Crohn's Disease
 Other: Blood sampling and biopsy
Other: Biopsy and blood sampling

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine if the patients reached by disease of crohn not presenting ASCA in their serum represent one under group of disease of crohn [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: June 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Patients with crohn disease
 Other: Blood sampling and biopsy
Biopsy and blood : Research for various antibodies
2
Patients reached by hemorrhagic first side-colitis
 Other: Biopsy and blood sampling
Biopsy and blood : research for various antibodies
3
Patients controls
 Other: Biopsy and blood sampling
Blood and biopsy : research for various antibodies

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769236

Contacts
Contact: Sophie Desplat-Jego, MD 0491383907 sophie.jego-desplat@ap-hm.fr

Locations
France
Laboratoire d'Immunologie - Hopital de la Conception Recruiting
Marseille, France, 13005
Contact: Sophie Desplat-Jego, MD     0491383907     sophie.jego-desplat@ap-hm.fr    
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Sophie Desplat-Jego, MD Assistance Publique des Hopitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00769236     History of Changes
Other Study ID Numbers: 2008-A00080-55, 2008-05
Study First Received: October 8, 2008
Last Updated: January 26, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Antibodies
Immunoglobulins
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013