Comparing Whole-Food Smoothie and Formula Nutrition for Children with Crohn's Disease
Compares whole-food blended smoothies with standard formula as nutrition for children with Crohn's disease.
Plain-language title generated from the registry record
Registry title: Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Key facts
- Where
- Halifax, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 21 years old?
Source: NCT06216899, who can take part
Where in Canada
- Izaak Walton Killam Health CentreHalifax, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seattle Children's Hospital
- Trial code
- NCT06216899
- Record updated
- 12 June 2025
- Original description
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).Read full original descriptionShow less
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 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.
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: corticosteroids (within 4 weeks),; 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; History of surgery for Crohn's disease; Perianal disease as part of Crohn's disease phenotype; Known allergies to any of the food components in the smoothie; Admission to hospital due to severity of Crohn's disease and associated symptoms; Recent use of:; dose adjustment of immunomodulator (within 8 week); Unwillingness to provide informed consent.