Comparing two types of nutrition for children with Crohn's disease
Official title: Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Run by Seattle Children's Hospital · NCT06216899 · Data updated 2026-11-12
This study is testing whether a regular nutrition formula or a homemade smoothie recipe works better for kids with Crohn's disease to see which one helps them feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 21 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Seattle Children's Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 3 sites (Philadelphia, Pennsylvania and 2 other locations) |
| Status | Recruiting |
| Started | March 11, 2024 |
| Main results expected | April 1, 2027 |
| Study ends | January 10, 2030 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT06216899 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 8 to 21 who have been diagnosed with Crohn's disease within the last 24 months and show active disease symptoms.
✕Probably not a fit
Patients with a history of surgery for Crohn's disease or those who have previously used biological medications or dietary therapies for Crohn's may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) with a whole-food blended smoothie EEN in pediatric patients newly diagnosed with Crohn's disease. A total of 60 participants aged 8 to 21 will be enrolled and provided either a commercial formula or guided on how to prepare a home-blended smoothie using specific recipes and ingredients. The study will last for 8 weeks, during which it will assess tolerance, clinical outcomes, stool microbiome, and quality of life among participants.
Why it matters
Potential benefit: If successful, this study could provide a more tolerable and effective nutritional approach for managing Crohn's disease in children.
How similar studies have gone: While there is limited data on the specific approach of using whole-food smoothies, similar studies on dietary interventions in Crohn's disease have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Seattle Children's Hospital
Seattle, Washington, United States Recruiting -
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Not yet recruiting -
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada Not yet recruiting
Study contacts
- Principal investigator: Dale Lee, MD, MSCE — Seattle Children's Hospital, University of Washington
- Study coordinator: Mason E Nuding
- Email: mason.nuding@seattlechildrens.org
- Phone: 206-987-0055
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.