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

NCT03458195 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

OTHER

bio-banking collection

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

Sponsors & Collaborators

  • Saint-Louis Hospital, Paris, France

    lead OTHER

Principal Investigators

  • Matthieu ALLEZ, Pr · Remind

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-10
Primary Completion
2030-12-31
Completion
2035-12-31

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03458195 on ClinicalTrials.gov