Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
ASCENSION
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.
2 other identifiers
interventional
120
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2022
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 2, 2021
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
March 27, 2026
March 1, 2026
4.1 years
February 26, 2021
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (22)
Change of wPCDAI from baseline to M2
2 months
Change of fecal calprotectin values from baseline to M2
2 months
Clinical remission at M2
2 months
Deep remission at M2
2 months
Physician global assessment (PGA) from baseline to M2
2 months
- +17 more secondary outcomes
Study Arms (3)
CDED/Modulen™IBD®
EXPERIMENTALStrategy combining CD exclusion diet plus Modulen™IBD® on top of ongoing maintenance therapy.
Unrestricted food access
ACTIVE COMPARATORStop CDED and Modulen™IBD®, but continue maintenance therapy with unrestricted food access.
Not randomized
OTHERPatient not in remission at M2 or refusing randomisation
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
- Informed and signed consent of parents
- Patient affiliated to social security (or health insurance)
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- MICALIS Institutecollaborator
- URC-CIC Paris Descartes Necker Cochincollaborator
Study Sites (4)
Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique
Bron, 69677, France
CHU Caen Normandie - Service de Gastroentérologie pédiatrique
Caen, 14033, France
Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique
Marseille, 13385, France
Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique
Paris, 75015, France
Related Publications (5)
Ruemmele FM, Veres G, Kolho KL, Griffiths A, Levine A, Escher JC, Amil Dias J, Barabino A, Braegger CP, Bronsky J, Buderus S, Martin-de-Carpi J, De Ridder L, Fagerberg UL, Hugot JP, Kierkus J, Kolacek S, Koletzko S, Lionetti P, Miele E, Navas Lopez VM, Paerregaard A, Russell RK, Serban DE, Shaoul R, Van Rheenen P, Veereman G, Weiss B, Wilson D, Dignass A, Eliakim A, Winter H, Turner D; European Crohn's and Colitis Organisation; European Society of Pediatric Gastroenterology, Hepatology and Nutrition. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014 Oct;8(10):1179-207. doi: 10.1016/j.crohns.2014.04.005. Epub 2014 Jun 6.
PMID: 24909831BACKGROUNDWynands J, Belbouab R, Candon S, Talbotec C, Mougenot JF, Chatenoud L, Schmitz J, Cezard JP, Goulet O, Hugot JP, Ruemmele FM. 12-month follow-up after successful infliximab therapy in pediatric crohn disease. J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):293-8. doi: 10.1097/MPG.0b013e31815604cd.
PMID: 18376247BACKGROUNDPigneur B, Lepage P, Mondot S, Schmitz J, Goulet O, Dore J, Ruemmele FM. Mucosal Healing and Bacterial Composition in Response to Enteral Nutrition Vs Steroid-based Induction Therapy-A Randomised Prospective Clinical Trial in Children With Crohn's Disease. J Crohns Colitis. 2019 Jul 25;13(7):846-855. doi: 10.1093/ecco-jcc/jjy207.
PMID: 30541015BACKGROUNDLevine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.
PMID: 31170412BACKGROUNDLevine A, Sigall Boneh R, Wine E. Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases. Gut. 2018 Sep;67(9):1726-1738. doi: 10.1136/gutjnl-2017-315866. Epub 2018 May 18.
PMID: 29777041BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franck Ruemmele, MD, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 2, 2021
Study Start
September 26, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share