Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU d'Amiens
NOT_YET_RECRUITING
Amiens
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU de Lille
NOT_YET_RECRUITING
Lille
HCL
NOT_YET_RECRUITING
Lyon
AP-HM
NOT_YET_RECRUITING
Marseille
CHU de Montpellier
NOT_YET_RECRUITING
Montpellier
Chu de Nice
NOT_YET_RECRUITING
Nice
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 42
Treatments
Active_comparator: Active arm
Early dosage of fecal calprotectin at 3 months
No_intervention: Standard arm
Standard dosage of fecal calprotectin at 6 months
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov