Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease

Prior treatment

• Previous total colectomy
• Short gut syndrome from prior surgeries
• Consuming parenteral nutrition for more than 350 calories per day in the two weeks prior to screening
• Having been on the Crohn's Disease Exclusion Diet (CDED) in the 2 weeks prior to screening
• Plan to receive two simultaneously administered advanced therapies
• Planning to start a new medication in the same class as the medication currently taking. This does not include a switch from Ustekinumab to anti-IL23 drugs.
• Impending need for CD surgery per investigator
• Starting a new medication for Crohn's disease other than steroids in the 8 weeks prior to the screening visit
• Has not consumed food in the last 6 days prior to screening
• Starting an accelerated (non-FDA approved) dose of advanced therapy

Other illness

• Diabetes mellitus requiring therapy with medication
• Known allergy to any ingredient in the Kate Farms formula.
• Untreated C. difficile infection with the last 8 weeks

Other

• Pregnancy or breast feeding
• Presence of an ostomy
• Symptomatic stricture or stricture inducing bowel dilation (\>3cm) as per local investigator.
• \>4 very soft or liquid bowel movements per day when feeling well
• Unable to complete online surveys
• Unable to receive shipments of PEN formula.
• At time of screening, participant is taking both Prednisone and Budesonide

• 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
• Active disease defined by at least one of the criteria from group A AND one from group B.
  • Group A
• Short Crohn's Disease Activity Index (sCDAI) score \>175, and if taking corticosteroids, dose cannot exceed 30 mg for prednisone or 9 mg for budesonide,
• sCDAI \< 175 and on 10- 30 mg of prednisone (or 6-9 mg of budesonide) at a stable dose for 2 weeks. Must have experienced worsening of symptoms with attempts to taper to a lower dose of steroids in 3 months prior to screening.
  • Group B
• Fecal calprotectin at baseline ≥ 300 ug/gr
• Active disease seen at colonoscopy within 8 weeks of the screening visit. Active disease requires presence of mucosal breaks including either diffuse scattered erosions or at least one ulcer (\>5mm diameter)
• Active disease on cross-sectional imaging (CT scan, MRI or ultrasound) within 8 weeks of the screening visit (evidence of acute inflammation, such as ulceration or bowel wall thickening with restricted diffusion)