EICHORCondition: Crohn Disease · Sponsor: Seattle Children's Hospital
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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.
This description comes directly from the study's public registry record.
Mason E Nuding · 206-987-0055 · mason.nuding@seattlechildrens.org
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06216899