Under construction – not a live service
Sign in
Taking people in FrancePhase 3

Tests a special diet with usual medicine in children with unstable Crohn's disease

Tests a special diet plus usual medicine in children with Crohn's disease.

Plain-language title generated from the registry record
Registry title: Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.

Key facts

Where
Bron, Caen, Marseille, and Paris, FranceSee the 4 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 6 to 17 with Crohn's disease that is still active despite their current medicines. It tests adding a Crohn's Disease Exclusion Diet to standard treatment.

Age
6 to 17 years
Sex
All sexes can join.
Disease stage
Crohn's disease confirmed for at least 3 months, with active disease (wPCDAI >12.5, or CRP more than 2 times the upper limit, or calprotectin >250µg/g if available).
Earlier treatment
The disease must be active despite anti-inflammatory medicines (5-ASA and derivatives), corticosteroids, immunomodulators (thiopurines or methotrexate) and/or biologic therapy (anti-TNF, anti-integrin, anti-IL23 antibodies).

Main reasons for not taking part

  • Active perianal fistulizing disease
  • Internal fistula or un-drained, uncontrolled abscess or phlegmon
  • Needing Crohn's-related surgery
  • Known allergy to cow's milk proteins
  • Pregnancy or breastfeeding

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Source: NCT04777656, who can take part

Where in France

  • Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatriqueBron, FranceContact: Rémi Duclaux-Loras, MD, PhDTaking people
  • CHU Caen Normandie - Service de Gastroentérologie pédiatriqueCaen, FranceContact: Claire Dupont-Lucas, MD, PhDTaking people
  • Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatriqueMarseille, FranceContact: Céline Roman, MD, PhDTaking people
  • Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatriqueParis, FranceContact: Franck Ruemmele, MD, PhDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Assistance Publique - Hôpitaux de Paris
Trial code
NCT04777656
Record updated
27 March 2026
Original description
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 CDEDRead full original descriptionShow less

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.

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

Inclusion: 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: Patient who require CD-related surgical therapy; Active perianal fistulizing disease; Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon; 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.

ClinicalTrials.gov NCT04777656