NCT06972901 Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
| NCT ID | NCT06972901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Crohn Disease (CD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2027-03-01 |
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 42 participants in total. It began in 2025-10-13 with a primary completion date of 2027-03-01.
⚠ 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) (\> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use of biotherapies, intestinal resections remain frequent (50% of patients over time). Unfortunately, surgery is not curative since 75% of patients experienced post-endoscopic operative recurrence (POR) (i.e., recurrence of ulcerations) during the first year after surgery. Prevention of endoscopic POR (defined as a Rutgeerts index ≥ i2) is essential because endoscopic POR is highly predictive of clinical POR (i.e., recurrence of CD-related symptoms): \> 40% and \> 80% within 5 years for a Rutgeerts index ≥ i2 or ≥ i3, respectively. The recommended management is to start treatment after surgery to avoid endoscopic POR, and to perform a colonoscopy at 6 months (M6) with therapeutic escalation if endoscopic POR. Despite anti-TNF or ustekinumab treatment, the endoscopic POR rate remains high (30-40% at M6) leading to \> 40% clinical POR despite therapeutic escalation (90 mg/4 weeks with ustekinumab) potentially due to late therapeutic escalation. Innovative strategies are therefore needed to prevent endoscopic POR, such as the use of fecal calprotectin, a non-invasive biomarker associated with endoscopic CD activity. We have previously demonstrated that its variation between surgery and M3 allows for a value at M3 predictive of endoscopic POR at M6. In this study, we hypothesize, for the first time, that a strategy integrating fecal calprotectin measurement at M3 with earlier therapeutic escalation (M3 vs M6) in case of abnormal value or kinetics could decrease the rate of endoscopic POR at M6.
Eligibility 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)
Contact & Investigator
Anthony Buisson
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT06972901 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06972901 currently recruiting?
Yes, NCT06972901 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT06972901 trial being conducted?
This trial is being conducted at Amiens, France, Clermont-Ferrand, France, Lille, France, Lyon, France and 4 additional locations.
Who is sponsoring the NCT06972901 clinical trial?
NCT06972901 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Anthony Buisson at University Hospital, Clermont-Ferrand. The trial plans to enroll 42 participants.