A Phase 3 interventional study of Phase1 : CDED/Modulen™IBD® + Maintenance therapy and Phase2 and 3 : in Crohn's Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 4 sites in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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
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). However, some patients, particularly in the pediatric age group do not respond with remission to standard therapy and approximately 30% of patients lose response to efficient therapy. There is a clear unmet need for new treatment strategies. In addition, patients and families have a high degree of reluctance to use IM/B as life-long medication, particularly due to potential side effects including cancer, lymphomas, serious infections or drug-related immune diseases. This is of particular importance for children/adolescents with CD, potentially exposed over many decades to various IM/B. Experimental and epidemiological data indicate that the western life style and particularly modern food play a key role in the development of CD, probably via alteration of the intestinal barrier function and/or enforcing the intestinal dysbiosis. Based on these data and the observation that exclusive enteral nutrition is highly efficacious in inducing remission in active CD, nutritional therapies are more and more in the focus for the development of new treatment approaches.
The main objective is to assess if the addition of 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.
To achieve this objective, eligible patients with active CD will participate to this study for a 13 months period. After a screening period, the patients will have a 2 months run-in phase where they will follow the CDED protocol, but continue their maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped at the end of the 2 months.
Then, the patients responding to CDED during run-in will be randomized at M2 to one of the two treatment arms (CDED/Modulen™IBD® or Unrestricted food access) and will have 4 follow-up visits (M4, M6, M9 and M12)
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Strategy combining CD exclusion diet plus Modulen™IBD® on top of ongoing maintenance therapy.
Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy · Dietary Supplement: Phase2 and 3 :
Stop CDED and Modulen™IBD®, but continue maintenance therapy with unrestricted food access.
Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy
Patient not in remission at M2 or refusing randomisation
Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy
from D0 until M2: Phase 1 (2 months run-in phase with CDED protocol + maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped until M2.)
from M2 until M4 CDED phase 2 (introduction of a selected number of additional food). From M4 until end of the study CDED phase 3 (enlargement of number of additional foods and allowance of some initially excluded foods).
Also known as: CDED/Modulen™IBD® + Maintenance therapy
Relapse from randomization until M12
Relapse is defined as weighted Paediatric Crohn's disease activity index (wPCDAI) \>40 points and/or CRP \>2 times over upper limit (in the absence of any obvious infections sign) or if at two consecutive visits (within 2-8 weeks) the wPCDAI is \>12,5 but less 40 and/or CRP \>1,5 but less 2 times over upper limit (in the absence of any obvious infections sign) or if the patient required additional CD-specific medication/surgery in the interval.
Time frame: 12 months
Change of wPCDAI from baseline to M2
Time frame: 2 months
Change of fecal calprotectin values from baseline to M2
Time frame: 2 months
Clinical remission at M2
Defined as wPCDAI ≤12.5 and normal CRP (≤1.5 fold upper normal range)
Time frame: 2 months
Deep remission at M2
Defined as wPCDAI ≤12.5 and normal CRP within normal lab range) and normal fecal calprotectin ((\<250µg/g)
Time frame: 2 months
Physician global assessment (PGA) from baseline to M2
Crohn's Disease activity assessed as remission - weak - moderate - severe
Time frame: 2 months
Mucosal healing at M2
absence of any ulcerations (including aphthae)
Time frame: 2 months
Endoscopic response at M2
Decrease of Crohn's Disease Endoscopic Index Score (CDEIS) ≥ 50% from baseline
Time frame: 2 months
Change of MRI from baseline to M2
Simplified Magnetic Resonance Index of Activity (MARIA) for Crohn's Disease score from baseline to M2
Time frame: 2 months
CDED tolerance rate at M2
serious and non serious adverse events
Time frame: 2 months
CDED compliance rate at M2
Time frame: 2 months
Change of intestinal microbiome composition from baseline to M2
Time frame: 2 months
Clinical remission
Defined as wPCDAI ≤12.5 and normal CRP (≤1.5 fold upper normal range)
Time frame: At 4 months, 6 months, 9 months and 12 months
Deep remission
Defined as wPCDAI ≤12.5 and normal CRP (within normal lab range) and normal fecal calprotectin (\<250µg/g)
Time frame: At 4 months, 6 months, 9 months and 12 months
Relapse
Defined as wPCDAI \>40 points and/or CRP \>2 times over upper limit (in the absence of any obvious infections sign) or if at two consecutive visits (within 2-8 weeks) the wPCDAI is \>12,5 but less 40 and/or CRP \>1,5 but less 2 times over upper limit (in the absence of any obvious infections sign) or if the patient required additional CD-specific medication/surgery in the interval
Time frame: At 4 months, 6 months, 9 months and 12 months
Physician global assessment (PGA)
Crohn's Disease activity assessed as remission - weak - moderate - severe
Time frame: At 4 months, 6 months, 9 months and 12 months
Mucosal Healing at M12
Absence of any ulcerations (including aphthae)
Time frame: 12 months
Endoscopic response at M12
Decrease of Crohn's Disease Endoscopic Index Score (CDEIS) ≥ 50% from baseline
Time frame: 12 months
Change of MRI from M2 to M12
Simplified Magnetic Resonance Index of Activity (MARIA) for Crohn's Disease score from M2 to M12
Time frame: 12 months
CDED tolerance rate at M12
Serious and non serious adverse events
Time frame: 12 months
CDED compliance rate at M12
Time frame: 12 months
Change of Intestinal microbiome composition
Time frame: At 4 months, 6 months, 9 months, 12 months
Change of quality of life IMPACT-3 from inclusion until 12 months
IMPACT-3 questionnaire of 35 closed questions - scale ranging from 1 to 5 for all answers - higher score suggesting better quality of life
Time frame: At baseline, 2 months, 4 months, 6 months, 9 months, 12 months
Plan to share: No
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