Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT03458195

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

Led by Saint-Louis Hospital, Paris, France · Updated on 2026-04-24

575

Participants Needed

17

Research Sites

1355 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent before any study activities
  • Diagnosed with Crohn's disease based on clinical, radiologic, endoscopic, or histological evidence
  • Men and women aged 18 years or older
  • Scheduled for ileocecal resection surgery
Not Eligible

You will not qualify if you...

  • History of dysplasia or cancer in the ileum or colon
  • Unable or unwilling to follow study procedures
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

SART Tilman Hospital

Liège, Belgium

Actively Recruiting

2

Amiens Hospital

Amiens, France, 80054

Actively Recruiting

3

Haut-levêque Hospital

Bordeaux, France, 33

Active, Not Recruiting

4

Clermont-Ferrand Hospital

Clermont-Ferrand, France, 63003

Actively Recruiting

5

Beaujon Hospital

Clichy, France, 92110

Actively Recruiting

6

Henri Mondor Hospital

Créteil, France

Actively Recruiting

7

Kremlin-Bicêtre Hospital

Le Kremlin-Bicêtre, France

Actively Recruiting

8

Lille Hospital

Lille, France, 59037

Actively Recruiting

9

Hôpital Nord, CHU Marseille

Marseille, France

Actively Recruiting

10

Montpellier Hospital

Montpellier, France

Actively Recruiting

11

Brabois Hospital

Nancy, France

Actively Recruiting

12

Nantes Hospital

Nantes, France, 44093

Actively Recruiting

13

Archet 2 Hospital

Nice, France, 06202

Actively Recruiting

14

Saint Louis Hospital

Paris, France, 75010

Actively Recruiting

15

Saint Antoine Hospital

Paris, France, 75012

Actively Recruiting

16

South Lyon Hospital

Pierre-Bénite, France, 69495

Actively Recruiting

17

Strasbourg Hospital

Strasbourg, France

Active, Not Recruiting

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Research Team

M

Matthieu ALLEZ, Pr

CONTACT

P

Philippe SEKSIK, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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