Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group

Trial Information
Who is this study for? Adult patients with Crohn's Disease
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
Summary

Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical recurrence occurs in 60% by 10 years. The principal factors affecting postoperative recurrence are active smoking, penetrating disease, perianal lesions history, prior intestinal resection, small bowel resection extent, and prophylaxis treatment absence. Ileocolonoscopy within one year of surgery can predict clinical recurrence risk. Different therapies are proposed after surgery, to prevent post-operative recurrence : Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy. Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role is clearly shown. Various changes in luminal flora with a possible link to local inflammation was also demonstrated. Bacteria associated with postoperative recurrence could be more pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through several mechanisms including increased mucosal colonization, adherence, replication and induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a protective commensal species lack, such as Faecalibacterium prausnitzii. Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are associated with different rates of postoperative recurrence. It suggests cytokines implication in postoperative recurrence. T cells are major players in the intestinal immune response. The presence at time of surgery and persistence of disease inducing T cell clonal expansions could play an important role in post-operative recurrence. The main objective is to define a classification of ileal Crohn's Disease based on data integration on a large cohort of patients.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Maximum Age:
100
Healthy Volunteers:
No

• Informed consent obtained before any study-related activities

• A diagnosis of CD, based on clinical, radiologic, endoscopic, or histological evidence.

• Men and women ≥18 years of age

• Required surgical intervention consisting in an ileocecal resection

Where is this trial taking place?
Other Locations
Belgium
SART Tilman Hospital
Recruiting
Liège
France
16 locations
Amiens Hospital
Recruiting
Amiens
Haut-levêque Hospital
Active, not recruiting
Bordeaux
Clermont-Ferrand Hospital
Recruiting
Clermont-ferrand
Beaujon Hospital
Recruiting
Clichy
Henri Mondor Hospital
Active, not recruiting
Créteil
Kremlin-Bicêtre Hospital
Recruiting
Le Kremlin-bicêtre
Lille Hospital
Recruiting
Lille
Hôpital Nord, CHU Marseille
Recruiting
Marseille
Montpellier Hospital
Recruiting
Montpellier
Brabois Hospital
Recruiting
Nancy
Nantes Hospital
Recruiting
Nantes
Archet 2 Hospital
Recruiting
Nice
Saint Antoine Hospital
Recruiting
Paris
Saint Louis Hospital
Recruiting
Paris
South Lyon Hospital
Recruiting
Pierre-bénite
Strasbourg Hospital
Active, not recruiting
Strasbourg
Who do I contact about this trial?
Primary
Matthieu ALLEZ, Pr
Matthieu.allez@aphp.fr
+33(1) 42 49 95 75
Backup
Philippe SEKSIK, Pr
Philippe.seksik@aphp.fr
+33(1) 49 28 31 62
When is this trial taking place?
Start Date: December 10, 2009
Estimated Completion Date: December 2026
How many participants will be in this trial?
Target number of participants: 575
What treatment is being studied in this trial?
Experimental: Crohn's disease patients
Patients aged 18 or more, for whom Crohn's disease diagnosis is confirmed and ileum or ileocecal Crohn's disease require surgical resection. in addition to usual practice, a bio-banking (blood samples, biopsies and surgical specimens) is collected.
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov