Actively Recruiting
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-27
120
Participants Needed
4
Research Sites
213 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
MICALIS Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child or adolescent aged 6 to 17 years
- Confirmed Crohn's disease diagnosis for at least 3 months with active disease
- Active disease defined by wPCDAI >12.5, or CRP >2 times upper limit, or calprotectin >250 µg/g if available
- For girls of childbearing age: negative pregnancy test and use of effective contraception
- Willingness to follow daily Crohn's Disease Exclusion Diet
- Signed informed consent from parents
- Affiliated to social security or health insurance
You will not qualify if you...
- Active perianal fistulizing disease
- Presence of internal fistula or un-drained/uncontrolled abscess or phlegmon
- Need for Crohn's disease-related surgical therapy
- Known allergy to cow milk proteins
- Inability to follow Crohn's Disease Exclusion Diet for a prolonged period
- Pregnancy or breastfeeding
- Already enrolled in another interventional study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique
Bron, France, 69677
Actively Recruiting
2
CHU Caen Normandie - Service de Gastroentérologie pédiatrique
Caen, France, 14033
Actively Recruiting
3
Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique
Marseille, France, 13385
Actively Recruiting
4
Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique
Paris, France, 75015
Actively Recruiting
Research Team
F
Franck Ruemmele, MD, PhD
CONTACT
P
Prissile Bakouboula, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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