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Immunological Consequences of CARD15/NOD2 Mutations in Crohn's Disease (PLAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00780949
First Posted: October 28, 2008
Last Update Posted: August 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The project is based on adult and paediatric cohorts among the largest ones in Paris and located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM Unit U843 in collaboration with the department of immunology and statistics, Robert Debré Hospital.

Condition Intervention
Crohn's Disease Other: intestinal biopsies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Immunological Consequences of CARD15/NOD2 Mutations in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • cytokine production and cell phenotype in Peyer patches [ Time Frame: final time frame at the end of the study ]

Enrollment: 110
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Crohn's disease patient
intestinal biopsies
Other: intestinal biopsies
intestinal biopsies during routine endoscopy
Other Name: intestinal biopsies during routine endoscopy

Detailed Description:

Crohn's Disease (CD) affects about 60.000 to 80.000 people in France. It is characterised by a chronic or relapsing inflammation of the gut. Its aetiology is largely unknown, limiting the development of preventive and curative therapeutic options. In 2001, we have identified the first CD susceptibility gene: CARD15/NOD2. This gene is involved in the innate immune response but we do not know today how gene mutations may induce the disease lesions. However, many data suggest that the intestinal inflammation may be related with an abnormal function of the lymphoid tissue present in the gut.

The aim of the present proposal is to better understand the role of CARD15/NOD2 mutations (R702W, G908R and 1007fs) in the development and the function of the intestinal lymphoid tissue. 250 patients and controls will be enrolled at Robert Debré and Saint Louis Hospital (Paris, France) within a 2 years period.

For participant, 4 to 5 ileal biopsies will be taken during a routine colonoscopy. Patients will be classed in three groups according to their number of CARD15/NOD2 mutations (1) wild-type, 2) mutated heterozygotes and 3) mutated homozygotes or compound heterozygotes). A comparison between groups and with non inflammatory (colonoscopy performed for other reasons) or inflammatory (ulcerative colitis patients) controls will be done. For each group, cell phenotype, cytokine profile, permeability and bacterial translocation will be analysed on Peyer's patches.

The project is based on adult and paediatric cohorts among the largest ones in Paris and located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM Unit U843 in collaboration with the department of immunology and statistics, Robert Debré Hospital.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adults ≥ 5 ans and ≤ 65 ans with a programmed routine colonoscopy for Crohn's disease, ulcerative colitis, or another benign gastroenterological disorder

Exclusion Criteria:

  • Patients < 5 ans or > 65 ans
  • Patients with contra-indications for multiple biopsies
  • Patients with an undeterminate colitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780949


Locations
France
Hopital Robert Debre
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Pierre HUGOT, Professeur Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00780949     History of Changes
Other Study ID Numbers: P071206
First Submitted: October 27, 2008
First Posted: October 28, 2008
Last Update Posted: August 3, 2012
Last Verified: July 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Crohn's Disease, inflammatory bowel disease, Peyer's patches

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases