Early fecal calprotectin testing to prevent Crohn's disease recurrence after bowel surgery
Tests early fecal calprotectin checks to guide treatment in adults with Crohn's disease after surgery.
Plain-language title generated from the registry record
Registry title: Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
Key facts
- Where
- Amiens, Clermont-Ferrand, Lille, Lyon, Marseille, Montpellier, Nice, and Toulouse, FranceSee the 8 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease who have had bowel surgery and are at higher risk of the disease coming back.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Crohn's disease after removal of part of the small bowel and/or colon (ileal, colonic or ileocolonic resection) with no visible disease left. The join between the bowel ends must be reachable by ileocolonoscopy.
- Earlier treatment
- At least one risk factor is needed. Examples are being a current smoker, an earlier bowel resection, more than 30 cm (12 in) of small bowel removed, fistulizing disease (B3), or at least two biotherapies before surgery. No contraindication to ustekinumab.
Main reasons for not taking part
- Permanent stoma
- Total colectomy
- Uncontrolled infection after the operation
- Pregnant or breastfeeding women
- Minors, protected adults under guardianship, or people deprived of liberty by a court or administrative decision
Read by machine on 12 November 2026.
Where in France
- CHU D'amiensAmiens, FranceContact: Lise LaclautreNot yet recruiting
- CHU de Clermont-FerrandClermont-Ferrand, FranceContact: Lise LaclautreTaking people
- CHU de LilleLille, FranceContact: Lise LaclautreNot yet recruiting
- HCLLyon, FranceContact: Lise LaclautreNot yet recruiting
- AP-HMMarseille, FranceContact: Lise LaclautreNot yet recruiting
- CHU de MontpellierMontpellier, FranceContact: Lise LaclautreNot yet recruiting
- CHU de NiceNice, FranceContact: Lise LaclautreNot yet recruiting
- CHU de ToulouseToulouse, FranceContact: Lise LACLAUTRENot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Clermont-Ferrand
- Trial code
- NCT06972901
- Record updated
- 5 June 2026
- Original description
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.Read full original descriptionShow less
Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
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.
Inclusion: 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: Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age; Permanent stoma; Total colectomy; Uncontrolled postoperative infectious complication; 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).