This is a multicenter non-randomized prospective open label trial of partial enteral nutrition (PEN) among patients with active Crohn's disease (CD) starting standard of care advanced therapy. Our central hypothesis is that combination therapy of PEN and pharmacologic therapy is more efficacious than pharmacologic therapy alone and can be well-tolerated for patients. Participants will choose to either include PEN along with starting their advanced therapy or will choose not to include PEN. 80 participants will be recruited from 15 sites across the United States.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Participants will consume Kate Farms Peptide 1.5 for approximately 60% of their calories while following the Crohn's Disease Exclusion Diet.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rate of steroid-free remission following 8 weeks of pharmacologic therapy
Steroid-free clinical remission at Visit 5 (week 8) of pharmacologic therapy initiation will be defined as a short Crohn's Disease Activity Index (sCDAI) \< 150 points while off steroids. The need to switch therapies, increase or initiate corticosteroids or any other CD drug will be considered as a failure to achieve the primary outcome.
Time frame: From start of pharmacologic therapy to 8 weeks.
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