NCT03508193 (RE-EEN) is a NA clinical trial of Nutritional therapy in Crohn Disease, sponsored by Dale Lee.

Who is sponsoring NCT03508193?

NCT03508193 is sponsored by Dale Lee.

What drugs are being tested in NCT03508193?

Interventions in NCT03508193: Nutritional therapy.

What condition does NCT03508193 study?

NCT03508193 studies Crohn Disease.

Is NCT03508193 still recruiting?

NCT03508193 is currently completed. Last updated 21 November 2022.

Last reviewed 2022-11-21 · How we verify

NCT03508193: RE-EEN

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

Reverse Engineering of Exclusive Enteral Nutrition

Completed NA Last updated 21 November 2022

What this trial tests

NA trial testing Nutritional therapy in Crohn Disease in 12 participants. Completed in 5 January 2022.

Timeline

4 November 2017

Primary endpoint
5 January 2022

5 January 2022

Quick facts

Lead sponsor	Dale Lee
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	4 November 2017
Primary completion	5 January 2022
Estimated completion	5 January 2022
Sites	1 location across United States

Drugs / interventions tested

Nutritional therapy

Conditions studied

Crohn Disease — all drugs for Crohn Disease →

Sponsor

Dale Lee

Who can join

Adults 8 to 21, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease. Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls. The specific aims of this proposal are: 1. To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease. 2. To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease. 3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.

Publications & conference data

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

Reverse-engineered exclusive enteral nutrition in pediatric Crohn's disease: A pilot trial.
Lee D, Braly K, Nuding M, Braly I, et al · · 2024 · cited 3× · PMID 38558411 · DOI 10.1002/jpn3.12196
Reverse-engineered exclusive enteral nutrition as induction therapy in pediatric Crohn's disease: Effects on environmental toxin exposure.
Reznikov EA, Melough MM, Lee DY, Suskind DL, et al · · 2026 · PMID 41038373 · DOI 10.1016/j.fct.2025.115773

Verify or expand the search:

Other trials of Nutritional therapy

Trials testing the same drug.

NCT06059560 — Nutritional Intervention for Patients With Multiple Cancer Types · NA · recruiting
NCT05347888 — How Well do we Feed the Critically Ill Patients · completed

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

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 NCT03508193 (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 Dale Lee
Last refreshed: 21 November 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/NCT03508193.

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