Using early fecal calprotectin to prevent Crohn's disease return after intestinal surgery
Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
This trial tests whether measuring fecal calprotectin early after bowel surgery and intensifying ustekinumab when levels rise can prevent Crohn's disease from coming back in adults at higher risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | ustekinumab |
| Locations | 8 sites (Amiens and 7 other locations) |
| Trial ID | NCT06972901 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with confirmed Crohn's disease who had an ileal, colonic, or ileocolic resection with an accessible anastomosis, at least one risk factor for postoperative recurrence, no contraindication to ustekinumab, and covered by the French healthcare system are eligible.
Not a fit: Patients with a permanent stoma or total colectomy, uncontrolled post‑op infection, contraindication to ustekinumab, pregnant or breastfeeding women, or those without risk factors for recurrence are unlikely to benefit from this strategy.
Why it matters
Potential benefit: If successful, this approach could lower early endoscopic recurrence rates and reduce later symptom relapse and need for further surgery.
How similar studies have performed: Observational and diagnostic studies consistently show fecal calprotectin predicts postoperative recurrence, but randomized trials that use early calprotectin to guide treatment intensification are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens and 7 other locations
- CHU d'Amiens — Amiens, France (Not_yet_recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (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)
- Chu de Nice — Nice, France (Not_yet_recruiting)
- CHU de Toulouse — Toulouse, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.