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NCT02843100: DIETOMICS-CD

Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease

Completed NA Last updated 1 June 2022
What this trial tests

NA trial testing Modified Exclusive Enteral Nutrition in Crohn's Disease in 63 participants. Completed in 29 May 2022.

Timeline
10 April 2018
Primary endpoint
29 May 2022
29 May 2022

Quick facts

Lead sponsorProf. Arie Levine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment63
Start date10 April 2018
Primary completion29 May 2022
Estimated completion29 May 2022
Sites7 locations across Ireland, Canada, Israel, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Prof. Arie Levine

Who can join

Adults 8 to 18, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Enteral nutritional therapy for induction of remission in Crohn's disease.
    Narula N, Dhillon A, Zhang D, Sherlock ME, et al · · 2018 · cited 144× · PMID 29607496 · DOI 10.1002/14651858.cd000542.pub3
  2. Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
    Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z
  3. Enteral nutrition for maintenance of remission in Crohn's disease.
    Akobeng AK, Zhang D, Gordon M, MacDonald JK. · · 2018 · cited 18× · PMID 30098021 · DOI 10.1002/14651858.cd005984.pub3
  4. Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease: Randomized Controlled Trial.
    Sigall Boneh R, Navas-López VM, Hussey S, Pujol-Muncunill G, et al · · 2025 · cited 6× · PMID 39732356 · DOI 10.1016/j.cgh.2024.12.006
  5. Reply to Cantarelli et al. Chronic Recurrent Multifocal Osteomyelitis Associated with Crohn Disease: A Potential Role of Exclusion Diet? Comment on "Starz et al. The Modification of the Gut Microbiota via Selected Specific Diets in Patients with Crohn's Disease. <i>Nutrients</i>
    Starz E, Wzorek K, Folwarski M, Kaźmierczak-Siedlecka K, et al · · 2021 · cited 3× · PMID 34836262 · DOI 10.3390/nu13114007
  6. Are Nutrition Interventions to Augment Treatment Plans the Most Personalized Approach to Inflammatory Bowel Disease Therapy?
    Barnes EL. · · 2020 · cited 1× · PMID 36776502 · DOI 10.1093/crocol/otaa043
  7. Abstract
    · 2025

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Other recruiting trials for Crohn's Disease

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02843100.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing