NCT03458195 Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group
| NCT ID | NCT03458195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saint-Louis Hospital, Paris, France |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 575 participants |
| Start Date | 2009-12-10 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 575 participants in total. It began in 2009-12-10 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Previous history of dysplasia or cancer in the ileum or colon * Unwillingness or inability to follow the procedures outlined in the protocol * Pregnant women
Contact & Investigator
Matthieu ALLEZ, Pr
PRINCIPAL INVESTIGATOR
Remind
Frequently Asked Questions
Who can join the NCT03458195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03458195 currently recruiting?
Yes, NCT03458195 is actively recruiting participants. Contact the research team at Matthieu.allez@aphp.fr for enrollment information.
Where is the NCT03458195 trial being conducted?
This trial is being conducted at Liège, Belgium, Amiens, France, Bordeaux, France, Clermont-Ferrand, France and 11 additional locations.
Who is sponsoring the NCT03458195 clinical trial?
NCT03458195 is sponsored by Saint-Louis Hospital, Paris, France. The principal investigator is Matthieu ALLEZ, Pr at Remind. The trial plans to enroll 575 participants.