Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
Not applicable · Testing Early faecal calprotectin dosage · 8 sites · University Hospital, Clermont-Ferrand
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Early faecal calprotectin dosage (a biologic) to see if it can prevent disease or complications. Condition(s) listed: Crohn Disease (CD), Ileocolic Resection and Post-endoscopic Operative Reccurence.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 5 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 42 participants are expected to take part.
- Start date: 2025-10-13.
- Main results expected around 2027-03-01 (estimate from the record).
- 8 study sites listed (1 marked recruiting) in France.
Main thing being measured
- Postoperative endoscopic recurrence (6 months post-operative)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Ileocolic Resection; Post-endoscopic Operative Reccurence |
| Lead sponsor | University Hospital, Clermont-Ferrand |
| Enrollment | 42 (estimated) |
| Start date | 2025-10-13 |
| Primary completion (est.) | 2027-03-01 |
| First posted | 2025-05-15 |
| Last updated | 2026-06-05 |
| Official title | Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin |
| ClinicalTrials.gov ID | NCT06972901 |
Interventions
- Early faecal calprotectin dosage (Biological)
An early dosage of faecal calprotectin will be done for the active arm group.
Full eligibility criteria (from the record)
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)
Locations (8)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d'Amiens | Amiens | France | Not yet recruiting |
| CHU de Clermont-Ferrand | Clermont-Ferrand | France | Recruiting |
| CHU de Lille | Lille | France | Not yet recruiting |
| HCL | Lyon | France | Not yet recruiting |
| AP-HM | Marseille | France | Not yet recruiting |
| CHU de Montpellier | Montpellier | France | Not yet recruiting |
| Chu de Nice | Nice | France | Not yet recruiting |
| CHU de Toulouse | Toulouse | France | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.