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NCT06216899 · ClinicalTrials.gov registry record · NA
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
A NA study of Crohn Disease, sponsored by Seattle Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT06216899: Recruiting NA study of Crohn Disease, sponsored by Seattle Children's Hospital.
NCT06216899 is a NA study of Crohn Disease that is actively recruiting participants, run by Seattle Children's Hospital. The registered enrollment target is 60 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (71% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06216899, a NA study of Crohn Disease, is actively recruiting participants, sponsored by Seattle Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.
Primary Outcome
Tolerance of therapy as measured by ability to continue prescribed nutritional therapy over 4-weeks and 8-weeks without deviation from protocol. Participants will meet with a study dietitian at week 2, week4, and week 8. Dietitians will evaluate caloric needs, specific deficits, and dietary limitations.
Conditions Studied
Interventions
- OTHER Whole-food based smoothie
- OTHER Formula
Study Locations (3)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Washington
- Seattle Children's Hospital - Seattle
Nova Scotia
- Izaak Walton Killam Health Centre - Halifax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-03-11 |
| Est. Completion | 2030-01-10 |
| Phase | NA |
What NCT06216899 shows while recruiting
NCT06216899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Whole-food based smoothie is the first listed.
NCT06216899 reports a single indexed study location in Pennsylvania, Washington, Nova Scotia.
Frequently Asked Questions
What is clinical trial NCT06216899 about?
NCT06216899 is a clinical study titled "Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial". This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or...
What is the current status of trial NCT06216899?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-03-11. Estimated completion is 2030-01-10.
What conditions does trial NCT06216899 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT06216899?
The interventions under investigation include: Whole-food based smoothie (OTHER), Formula (OTHER).
Who is sponsoring clinical trial NCT06216899?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06216899 being conducted?
This trial has 3 study locations across Pennsylvania, Washington, Nova Scotia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06216899's enrollment target sits among peer trials
60 43rd of 71 higher than 28 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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