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NCT03458195Recruiting

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

Source: ClinicalTrials.gov · Last updated 24 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
575 (estimated)
First submitted
1 Mar 2018
Start date
10 Dec 2009
Primary completion date
31 Dec 2030
Lead sponsor
Saint-Louis Hospital, Paris, France
NCT number
NCT03458195

What you commit to

  • Study type: Interventional
  • Planned participants: 575
  • From 10 Dec 2009 to the primary completion date, 31 Dec 2030
  • 17 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of dysplasia or cancer in the ileum or colon

Other

  • Unwillingness or inability to follow the procedures outlined in the protocol
  • Pregnant women

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SART Tilman Hospital
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LiègeBelgiumRecruiting
Amiens hospital
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AmiensFranceRecruiting
Haut-Lévêque Hospital
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BordeauxFranceActive, not recruiting
Clermont-Ferrand Hospital
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Clermont-FerrandFranceRecruiting
Beaujon Hospital
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ClichyFranceRecruiting
Henri Mondor Hospital
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CréteilFranceRecruiting
Kremlin-Bicêtre Hospital
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Le Kremlin-BicêtreFranceRecruiting
Lille Hospital
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LilleFranceRecruiting
Hôpital Nord - Chu Marseille
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MarseilleFranceRecruiting
Montpellier Hospital
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MontpellierFranceRecruiting
Brabois Hospital
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NancyFranceRecruiting
Nantes Hospital
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NantesFranceRecruiting
Archet 2 Hospital
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NiceFranceRecruiting
Saint Louis Hospital
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ParisFranceRecruiting
Saint-Antoine Hospital
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ParisFranceRecruiting
South Lyon Hospital
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Pierre-BéniteFranceRecruiting
Strasbourg Hospital
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StrasbourgFranceActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.