Status:
RECRUITING
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
MICALIS Institute
Conditions:
Crohn's Disease
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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...
Detailed Description
Crohn's disease is a recurrent inflammatory disorder. Current treatment strategies aim reducing intestinal (and systemic) inflammation based on the use of Immunomodulators (IM) and biologics (B). Howe...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04777656
Start Date
September 26 2022
End Date
November 1 2026
Last Update
November 1 2022
Active Locations (4)
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1
Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique
Bron, France, 69677
2
CHU Caen Normandie - Service de Gastroentérologie pédiatrique
Caen, France, 14033
3
Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique
Marseille, France, 13385
4
Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique
Paris, France, 75015