Phase
Condition
N/ATreatment
Formula
Whole-food based smoothie
Clinical Study ID
Ages 8-21 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 iscapable of giving informed consent.
Exclusion
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.
Study Design
Connect with a study center
Izaak Walton Killam Health Centre
Halifax, Nova Scotia B3J 0C3
CanadaSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19146
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting

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