Using early fecal calprotectin to prevent Crohn's disease return after intestinal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, multicenter, randomized two-arm trial enrolling adults after ileal, colonic, or ileocolic resection for Crohn's disease who have at least one risk factor for postoperative recurrence. Participants are randomized to standard care (routine monitoring with colonoscopy at 6 months and treatment escalation based on endoscopy) or an active strategy that uses a fecal calprotectin test at week 10 to trigger earlier ustekinumab intensification if levels are >100 μg/g or rise by >50 μg/g from baseline. Randomization is stratified by center and number of risk factors, and monitoring includes clinical visits and laboratory assessments; endoscopic recurrence (Rutgeerts index ≥ i2) is the key endpoint. The trial is conducted at French university hospitals with sequential offering of participation by investigators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with an established diagnosis of CD according to ECCO guidelines
* Adult Crohn's disease (age ≥ 18 years)
* Having undergone ileal, colonic, or ileocolonic resection without residual macroscopic lesions
* With an anastomosis that can be reached by ileocolonoscopy
* With at least one of the following risk factors for endoscopic POR: active smoking, previous intestinal resection (before the current resection), length of resected small bowel \> 30 cm, fistulizing phenotype (B3 according to the Montreal classification), exposure to at least two biotherapies before surgery
* No contraindication to ustekinumab treatment
* Patient capable of giving consent
* Patient covered by the French healthcare system

Exclusion Criteria:

* Permanent stoma
* Total colectomy
* Uncontrolled postoperative infectious complication
* Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age
* Refusal to participate in the study
* Persons deprived of their liberty by judicial or administrative decision
* Minors
* Vulnerable protected adults (under guardianship, curatorship, or legal protection)

Where it's running

• CHU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• CHU d'Amiens
  Amiens, France Not yet recruiting
• CHU de Lille
  Lille, France Not yet recruiting
• Hcl
  Lyon, France Not yet recruiting
• Ap-Hm
  Marseille, France Not yet recruiting
• CHU de Montpellier
  Montpellier, France Not yet recruiting

Study contacts

• Principal investigator: Anthony Buisson — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: 334.73.754.963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.