NCT04777656RecruitingPhase 3
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.
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 26 Feb 2021
- Start date
- 26 Sept 2022
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Crohn's disease
- NCT number
- NCT04777656
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 26 Sept 2022 to the primary completion date, 30 Nov 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who require CD-related surgical therapy
Other illness
- 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
Other
- Patient incapable to follow CDED for a prolonged period
- Pregnancy, breastfeeding
- Patient already included in an interventional study
Who the study is looking for
- 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)
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| CHU Caen Normandie - Service de Gastroentérologie pédiatrique Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.