NCT04777656 Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
| NCT ID | NCT04777656 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-09-26 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2022-09-26 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Franck Ruemmele, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04777656 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04777656 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT04777656 currently recruiting?
Yes, NCT04777656 is actively recruiting participants. Contact the research team at frank.ruemmele@aphp.fr for enrollment information.
Where is the NCT04777656 trial being conducted?
This trial is being conducted at Bron, France, Caen, France, Marseille, France, Paris, France.
Who is sponsoring the NCT04777656 clinical trial?
NCT04777656 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Franck Ruemmele, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 120 participants.
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