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Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
This research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED
Official title: Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone.
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2022-09-26
Completion Date
2026-11
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Phase1 : CDED/Modulen™IBD® + Maintenance therapy
from D0 until M2: Phase 1 (2 months run-in phase with CDED protocol + maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped until M2.)
Phase2 and 3 :
from M2 until M4 CDED phase 2 (introduction of a selected number of additional food). From M4 until end of the study CDED phase 3 (enlargement of number of additional foods and allowance of some initially excluded foods).
Locations (4)
Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique
Bron, France
CHU Caen Normandie - Service de Gastroentérologie pédiatrique
Caen, France
Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique
Marseille, France
Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique
Paris, France