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.
Sponsor study identifier
Secondary identifiers
OTHER · ID-RCB
interventional
120
1 country
4
Study Start
September 26, 2022
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2021
Actual (reported)March 2, 2021
Actual (reported)September 26, 2022
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Strategy combining CD exclusion diet plus Modulen™IBD® on top of ongoing maintenance therapy.
Stop CDED and Modulen™IBD®, but continue maintenance therapy with unrestricted food access.
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.)
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
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.
Wynands 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.
Franck Ruemmele, MD, PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
February 26, 2021
First Posted
March 2, 2021
Study Start
September 26, 2022
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Vagus Nerve Stimulation a New Approach in the Treatment of Crohn's Disease
Patient not in remission at M2 or refusing randomisation
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique
Marseille, 13385, France
Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique
Paris, 75015, France
Pigneur 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.
Levine 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.
Levine 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.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 27, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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