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RE-EEN Study: Whole-Food Smoothies vs. Formula for Crohn's Disease

This study is comparing two ways to provide nutrition for children and young adults (ages 8-21) with newly diagnosed Crohn's disease. You would receive either a whole-food based smoothie or a conventional formula (like Boost or Ensure) to meet your caloric needs. The goal is to see which approach is easier to tolerate and more effective. To join, you need to have Crohn's disease diagnosed within the last 24 months and show signs of active inflammation through blood tests (C-reactive protein, ESR) or a stool test (fecal calprotectin), and have a Pediatric Crohn's Disease Activity Index (PCDAI) score of 10 or higher. The study aims to enroll 60 participants and is currently unclear about its recruitment status.

Study design
This is an interventional study comparing two different nutritional approaches. It plans to enroll 60 participants.
What's involved
You would be on a specific nutritional therapy for 8 weeks. This includes receiving either commercial formula or guidance, a recipe, a blender, and food components for a home-blended smoothie.
Compensation
Not stated in the trial record.
Follow-up
The study assesses tolerance at 4 and 8 weeks, indicating a follow-up period of at least 8 weeks.

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NCT06216899

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

Recruiting
NAAges 8–21InterventionalTreatment
Seattle Children's Hospital
~60 participants
Updated 2025-06-12 on ClinicalTrials.gov
What's tested:Whole-food based smoothieFormula

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tolerance- Ability to remain on prescribed nutritional therapy
Measured over 4 and 8 weeks

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

3 sites across 3 states
Pennsylvania1
Washington1
Nova Scotia1

Study leadership

  • Dale Lee, MD, MSCE · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital, University of Washington

Who to contact

Mason E Nuding
[email protected]
206-987-0055
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Tolerance- Ability to remain on prescribed nutritional therapy4 and 8 weeks

    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.