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.
Ability to provide informed consent
A confirmed diagnosis of Crohn's disease
Plan to start one advanced Crohn's Disease therapy (anti-TNF, anti-IL12/IL23, anti-IL23, anti-alpha 4 beta 7, JAK inhibitor).
If taking aminosalyilates, methotrexate or thiopurines, participant must be on a stable does for at least 8 weeks prior to screening. Methotrexate, aminosalicylates and thiopurines are permitted to be continued with the advanced therapy if on stable dose for at least 8 weeks. Methotrexate or thiopurines may be initiated within 1 week of starting the advanced pharmacologic therapy
Pregnancy or breast feeding
Presence of an ostomy
Previous total colectomy
Short gut syndrome from prior surgeries
Parallel
Partial enteral nutrition - orally consumed formula
Dietary supplementParticipants will consume Kate Farms Peptide 1.5 for approximately 60% of their calories while following the Crohn's Disease Exclusion Diet.
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.
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