Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Not applicable · Testing Whole-food based smoothie and Formula · 3 sites · Seattle Children's Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Whole-food based smoothie and Formula as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 8 to 21
- Any sex
Some of the main requirements, copied from the record:
- Age 8 -21 years old.
- Diagnosis of Crohn's disease within 24 months
- Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
Plus 2 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2024-03-11.
- Main results expected around 2027-04-01 (estimate from the record).
- 3 study sites listed (1 marked recruiting) in Canada and United States.
Main thing being measured
- Tolerance- Ability to remain on prescribed nutritional therapy (4 and 8 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Seattle Children's Hospital |
| Collaborators | Children's Hospital of Philadelphia; Dalhousie University |
| Enrollment | 60 (estimated) |
| Start date | 2024-03-11 |
| Primary completion (est.) | 2027-04-01 |
| First posted | 2024-01-22 |
| Last updated | 2025-06-12 |
| Official title | Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial |
| ClinicalTrials.gov ID | NCT06216899 |
Interventions
- Whole-food based smoothie (Other)
The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition and provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs. - Formula (Other)
Conventional formula (Boost, Ensure, Modulen) as per the direction of their primary Gastroenterology team to provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.
Full eligibility criteria (from the record)
Inclusion Criteria: * Age 8 -21 years old. * Diagnosis of Crohn's disease within 24 months * Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin * Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10. * Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent. Exclusion Criteria: * History of surgery for Crohn's disease. * Perianal disease as part of Crohn's disease phenotype. * Recent use of: * corticosteroids (within 4 weeks), * dose adjustment of immunomodulator (within 8 week) * azathioprine 4 weeks prior to study final visit (week 8) * start or adjust methotrexate 3 weeks prior to final study visit. * Prior use of biological medication * Prior treatment with EEN or other dietary therapy for Crohn's disease. * Prior treatment with antibiotics for Crohn's disease. * Known allergies to any of the food components in the smoothie. * Admission to hospital due to severity of Crohn's disease and associated symptoms. * Unwillingness to provide informed consent.
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania | United States | Not yet recruiting |
| Seattle Children's Hospital | Seattle, Washington | United States | Recruiting |
| Izaak Walton Killam Health Centre | Halifax, Nova Scotia | Canada | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.