Comparing two types of nutrition for children with Crohn's disease
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 3 sites (Philadelphia, Pennsylvania and 2 other locations) |
| Trial ID | NCT06216899 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Philadelphia, Pennsylvania and 2 other locations
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.