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RECRUITINGPhase 3INTERVENTIONAL

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

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Child/Adolescent aged 6-17 years with a confirmed diagnosis of CD (for at least 3 months) with an active disease (defined as: wPCDAI \>12.5 or CRP \> 2 times upper limit or calprotectin levels \>250µg/g if available) despite anti-inflammatory (5-ASA and derivates), corticosteroids, immunomodulator (thiopurines or methotrexate) and/or biologic therapy (anti-TNF, anti-integrin anti-IL23 antibodies) - For girls of childbearing age: a negative pregnancy test, and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom) - Patient willing to comply with daily intake of an exclusion diet - Informed and signed consent of parents - Patient affiliated to social security (or health insurance) Who Should NOT Join This Trial: - Active perianal fistulizing disease - Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon - Patient who require CD-related surgical therapy - Patient with known allergy to cow milk's proteins - Patient incapable to follow CDED for a prolonged period - Pregnancy, breastfeeding - Patient already included in an interventional study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Child/Adolescent aged 6-17 years with a confirmed diagnosis of CD (for at least 3 months) with an active disease (defined as: wPCDAI \>12.5 or CRP \> 2 times upper limit or calprotectin levels \>250µg/g if available) despite anti-inflammatory (5-ASA and derivates), corticosteroids, immunomodulator (thiopurines or methotrexate) and/or biologic therapy (anti-TNF, anti-integrin anti-IL23 antibodies) * For girls of childbearing age: a negative pregnancy test, and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom) * Patient willing to comply with daily intake of an exclusion diet * Informed and signed consent of parents * Patient affiliated to social security (or health insurance) Exclusion Criteria: * Active perianal fistulizing disease * Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon * Patient who require CD-related surgical therapy * Patient with known allergy to cow milk's proteins * Patient incapable to follow CDED for a prolonged period * Pregnancy, breastfeeding * Patient already included in an interventional study

Treatments Being Tested

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).

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