A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD). (PCE)
Inflammatory Bowel Diseases, Children, Only
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Diseases focused on measuring colon capsule endoscopy
Eligibility Criteria
Inclusion Criteria:
- diagnosis of Crohn's Disease made at least 3 months before the enrolment;
- subject was referred for endoscopic and imaging follow-up in Crohn's Disease
- signed informed consent.
Exclusion Criteria:
- Subject has dysphagia
- Subject has renal insufficiency
- Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Pan-enteric capsule endoscopy (PCE)
Evidence of active disease by PCE prompted a change in therapy at the discretion of the treating clinician and according to current available pediatric guidelines. The definition of medical treatment adjustment after evidence of inflammation was: the introduction of steroids or enteral nutrition, the introduction or optimization of immunosuppressives; the introduction, optimization of biologics; or the introduction of both immunosuppressive agents and biologics. In case of a negative PCE and presence of symptoms, the magnetic resonance enterography (MRE) could help in guiding therapeutic decisions.