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RECRUITING
NCT03458195
NA

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

Sponsor: Saint-Louis Hospital, Paris, France

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

575

Start Date

2009-12-10

Completion Date

2026-12

Last Updated

2024-04-18

Healthy Volunteers

No

Conditions

Interventions

OTHER

bio-banking collection

blood samples, biopsies, and surgical specimen collected in addition to usual practice

Locations (17)

SART Tilman Hospital

Liège, Belgium

Amiens Hospital

Amiens, France

Haut-levêque Hospital

Bordeaux, France

Clermont-Ferrand Hospital

Clermont-Ferrand, France

Beaujon Hospital

Clichy, France

Henri Mondor Hospital

Créteil, France

Kremlin-Bicêtre Hospital

Le Kremlin-Bicêtre, France

Lille Hospital

Lille, France

Hôpital Nord, CHU Marseille

Marseille, France

Montpellier Hospital

Montpellier, France

Brabois Hospital

Nancy, France

Nantes Hospital

Nantes, France

Archet 2 Hospital

Nice, France

Saint Louis Hospital

Paris, France

Saint Antoine Hospital

Paris, France

South Lyon Hospital

Pierre-Bénite, France

Strasbourg Hospital

Strasbourg, France