AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 3Ages 6 Years - 17 YearsAllAssistance Publique - Hôpitaux de Paris
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • Phase1 : CDED/Modulen™IBD® + Maintenance therapy
  • Phase2 and 3 :
📍

Where

4 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy