RecruitingNot ApplicableNCT06972901

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

42 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a simple stool test (measuring a protein called calprotectin) taken 3 months after bowel surgery for Crohn's disease can predict whether the disease will come back, helping doctors decide when to start or adjust preventive treatment. **You may be eligible if...** - You have a confirmed diagnosis of Crohn's disease - You are 18 or older and recently had surgery to remove part of your intestine, with no visible disease remaining - Your bowel connection (anastomosis) can be reached with a colonoscope - You have at least one risk factor for Crohn's coming back (e.g., you smoke, had previous intestinal surgery, had a long section removed, had fistulizing disease, or were on two or more biologic therapies before surgery) - You have no contraindication to ustekinumab (a biologic medication) **You may NOT be eligible if...** - You have active, visible Crohn's disease remaining after surgery - You cannot consent or comply with the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEarly faecal calprotectin dosage

An early dosage of faecal calprotectin will be done for the active arm group.


Locations(8)

CHU d'Amiens

Amiens, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CHU de Lille

Lille, France

HCL

Lyon, France

AP-HM

Marseille, France

CHU de Montpellier

Montpellier, France

Chu de Nice

Nice, France

CHU de Toulouse

Toulouse, France

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NCT06972901


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