NCT05284136

Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease

Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Crohn's disease exclusion diet (CDED)	16-week course of CDED+Partial Enteral Nutrition. During the first 6 weeks (phase 1 of CDED), patients will be prescribed the CDED and oral Modulen 1 liter (1000kcal) daily. Between week 6 and 16 (phase 2 of CDED), patients will be prescribed CDED and oral Modulen (500 mL).
DRUG	Oral prednisolone	oral prednisolone at an initial dose of 40 to 60 mg/day (or 1 mg/kg for those patients who weigh less than 40 kg), with a fixed, tapering regimen such that patients should be off steroids by the last day of week 12. Increases in steroid dose during tapering of corticosteroids is allowed but if the patient receives steroids (other than hydrocortisone for adrenal insufficiency) after week 12, he/she is in failure.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-08-01
• Completion: 2026-04-01
• First posted: 2022-03-17
• Last updated: 2022-03-17

Locations

2 sites across 2 countries: France, Netherlands