Crohn's Disease Exclusion Diet combined with standard therapy for children with Crohn's disease
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.
PHASE3 · Assistance Publique - Hôpitaux de Paris · NCT04777656
This study is testing if adding a special diet to regular treatment can help children with Crohn's disease feel better and stay well longer.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | methotrexate |
| Locations | 4 sites (Bron and 3 other locations) |
| Trial ID | NCT04777656 on ClinicalTrials.gov |
What this trial studies
This multicenter French clinical trial evaluates the effectiveness of the Crohn's Disease Exclusion Diet (CDED) in conjunction with standard medication for pediatric patients suffering from unstable Crohn's disease. The study aims to determine if adding CDED can reduce relapse rates over a 12-month period compared to standard therapy alone. Participants will include children and adolescents aged 6-17 who have been diagnosed with Crohn's disease and have not achieved remission despite existing treatments. The trial is randomized and single-blinded, focusing on a novel dietary approach to complement traditional medical therapies.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6-17 with a confirmed diagnosis of Crohn's disease who are experiencing active disease despite current therapies.
Not a fit: Patients with active perianal fistulizing disease or those requiring surgical intervention for Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for children with Crohn's disease, potentially reducing reliance on long-term medication.
How similar studies have performed: While dietary interventions in Crohn's disease are gaining attention, this specific approach using CDED is relatively novel and has not been extensively tested in similar trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bron and 3 other locations
- Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique — Bron, France (RECRUITING)
- CHU Caen Normandie - Service de Gastroentérologie pédiatrique — Caen, France (RECRUITING)
- Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique — Marseille, France (RECRUITING)
- Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Franck Ruemmele, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Franck Ruemmele, MD, PhD
- Email: frank.ruemmele@aphp.fr
- Phone: +33 (0)1 44 49 25 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn's Disease, Crohn's disease, Recurrent inflammatory disorder, Immunomodulators, Biologics, Exclusive Enteral Nutrition, Crohn's disease exclusion diet, Modulen™IBD®