NCT04921033 is a Phase 3 clinical trial of EEN (Nestle Modulen®) in Crohn Disease, sponsored by Duzce University.

Who is sponsoring NCT04921033?

NCT04921033 is sponsored by Duzce University.

What drugs are being tested in NCT04921033?

Interventions in NCT04921033: EEN (Nestle Modulen®), Standart of care.

What condition does NCT04921033 study?

NCT04921033 studies Crohn Disease, Nutrient; Excess, Remission/Regression.

Is NCT04921033 still recruiting?

NCT04921033 is currently status unknown. Last updated 18 October 2022.

Last reviewed 2022-10-18 · How we verify

NCT04921033

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease

Status unknown Phase 3 Last updated 18 October 2022

What this trial tests

Phase 3 trial testing EEN (Nestle Modulen®) in Crohn Disease in 256 participants. Status unknown.

Timeline

1 March 2021

Primary endpoint
1 January 2026

1 January 2026

Quick facts

Lead sponsor	Duzce University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	256
Start date	1 March 2021
Primary completion	1 January 2026
Estimated completion	1 January 2026
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

EEN (Nestle Modulen®)
Standart of care — full drug profile →

Conditions studied

Crohn Disease — all drugs for Crohn Disease →
Nutrient; Excess — all drugs for Nutrient; Excess →
Remission/Regression — all drugs for Remission/Regression →

Sponsor

Duzce University

Who can join

Adults 18 to 75, any sex, with Crohn Disease or Nutrient; Excess. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background. One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Nutrients alter the intestinal microbiota, thus changing the intestinal permeability. The Western-type diet encompasses sugar, fat, and protein-rich products that have some deleterious effects on the intestinal microbiome compared to the plant-based Mediterranean-type diet. Based on this fact, diet-based therapeutic efforts have been used extensively in pediatric Crohn's disease patients and there is strong evidence that exclusive enteral nutrition (EEN) is as effective as corticosteroids to induce both clinical and endoscopic remission but this treatment strategy is underutilized in adults.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

TGF-β signaling in health, disease, and therapeutics.
Deng Z, Fan T, Xiao C, Tian H, et al · · 2024 · cited 737× · PMID 38514615 · DOI 10.1038/s41392-024-01764-w

Verify or expand the search:

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting

Other Duzce University trials

Trials by the same sponsor.

NCT07300176 — Virtual Reality-Assisted Intraoperative Sensory Modulation on Postpartum Depression and the Kynurenine Pathway · active not recruiting
NCT07163468 — Neuromusculoskeletal Alterations After ACL Injury · completed
NCT07468240 — Mindfulness-Based Psychoeducation for Burnout, Decision-Making, and Existential Anxiety in High-Risk Unit Nurses · NA · completed
NCT07152093 — Development of an Artificial Intelligence-Based Model for Predicting Difficult Intubation Using Video Laryngoscopic Imag · completed
NCT07057362 — Effect of Vitamin D Deficiency on the Frequency and Severity of Spinal Anesthesia-Induced Hypotension in Pregnant Women · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04921033 (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 Duzce University
Last refreshed: 18 October 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/NCT04921033.

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