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

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

August 1, 2025

Study Completion Date

April 1, 2026

Conditions
Crohn Disease
Interventions
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.

Trial Locations (2)

94

Gastroenterology department, Le Kremlin-Bicêtre

1105 AZ

Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC, Amsterdam

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT05284136 - Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease | Biotech Hunter | Biotech Hunter