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Study identifier: NCT06972901 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Crohn Disease (CD) · Ileocolic Resection · Post-endoscopic Operative Reccurence  ·  Sponsor: University Hospital, Clermont-Ferrand

PhaseNA
Planned participants42
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Lise Laclautre  ·  334.73.754.963  ·  promo_interne_drci@chu-clermontferrand.fr

Always discuss trial participation with your own doctor first.

Locations (8)

CHU d'AmiensAmiens, FranceNot Yet Recruiting
CHU de Clermont-FerrandClermont-Ferrand, FranceRecruiting
CHU de LilleLille, FranceNot Yet Recruiting
HCLLyon, FranceNot Yet Recruiting
AP-HMMarseille, FranceNot Yet Recruiting
CHU de MontpellierMontpellier, FranceNot Yet Recruiting
Chu de NiceNice, FranceNot Yet Recruiting
CHU de ToulouseToulouse, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06972901