Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease
Status:
Not yet recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
Crohn's disease exclusion diet (CDED) is a whole-food diet coupled with partial enteral
nutrition. The main objective of this trial is to assess whether CDED is superior to
corticosteroids, in terms of endoscopic response, in patients active CD. The primary endpoint
is endoscopic response at week 16, without corticosteroids or further therapeutic
intervention, assessed by a centralized, anonymous and blinded, double lecture panel of
panenteric PillCam Crohn's Capsule. This is a multicentre, open-label, comparative,
randomized, 2:1, controlled, single-blind, superiority trial. Patients included are aged 16
to 70 years, have mild to moderate, luminal, active CD, and have active endoscopic lesions.
Eighty patients will be randomized between CDED (n=56) and corticosteroids (n=24) in centres
in France, Israel and the Netherlands.