Last reviewed · How we verify
NCT02843100: DIETOMICS-CD
Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease
NA trial testing Modified Exclusive Enteral Nutrition in Crohn's Disease in 63 participants. Completed in 29 May 2022.
29 May 2022
Quick facts
| Lead sponsor | Prof. Arie Levine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 10 April 2018 |
| Primary completion | 29 May 2022 |
| Estimated completion | 29 May 2022 |
| Sites | 7 locations across Ireland, Canada, Israel, Spain |
Drugs / interventions tested
- Modified Exclusive Enteral Nutrition
- Crohn's Disease Exclusion Diet
- Partial Enteral Nutrition
- Standard Exclusive Enteral Nutrition
Conditions studied
- Crohn's Disease — all drugs for Crohn's Disease →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
Abstract
· 2025
Verify or expand the search:
- PubMed search for NCT02843100
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184931 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Prof. Arie Levine trials
Trials by the same sponsor.
- NCT03980405 — Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis · NA · terminated
- NCT02345733 — Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02843100 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prof. Arie Levine
- Last refreshed: 1 June 2022
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