PARADISE. Randomized therapeutic trial in active Crohn’s disease in children and adults: Comparison of an exclusion diet with corticosteroids
The Crohn’s Disease Exclusion Diet (CDED) is designed to reduce exposure to dietary components that may have deleterious effects on the microbiome, the intestinal barrier and intestinal immunity. It is a complete diet coupled with partial enteral nutrition. The primary objective of this trial is to assess whether CDED is superior to corticosteroids, in terms of endoscopic response, in patients with active CD. The primary endpoint is endoscopic response at week 16, without corticosteroids or other therapeutic intervention, as assessed by a centralized, anonymous, blinded, double-reading panel of the PillCam Crohn’s Capsule panenteric. One of the secondary objectives is to compare the gut microbiome in the 2 study arms (CDED vs corticosteroids) at baseline, week 6 and week 16. The composition and functions of the microbiome will be determined. Changes in other microorganism components (protista, fungi and viruses) will also be assessed.
Coordination: Franck CARBONNEL - Gastroenterology Department, APHP Bic?tre
Main partners: Department of Gastroenterology & Hepatology, Amsterdam UMC (G. D’Haens) Department of Gastroenterology, Tel Aviv Medical Center, Israel (N. Maharshak) INRAE - Institut Micalis - PhylHom (P. Lepage)