Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.

PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 26, 2022

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Crohn's Disease
Interventions
DIETARY_SUPPLEMENT

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.)

DIETARY_SUPPLEMENT

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).

Trial Locations (4)

13385

RECRUITING

Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique, Marseille

14033

RECRUITING

CHU Caen Normandie - Service de Gastroentérologie pédiatrique, Caen

69677

RECRUITING

Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique, Bron

75015

RECRUITING

Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

collaborator

MICALIS Institute

UNKNOWN

lead

Assistance Publique - Hôpitaux de Paris

OTHER