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

Overview

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.

Interventions

• Dietary supplement Partial enteral nutrition - orally consumed formula
  Participants will consume Kate Farms Peptide 1.5 for approximately 60% of their calories while following the Crohn's Disease Exclusion Diet.

Primary outcome measures

• Rate of steroid-free remission following 8 weeks of pharmacologic therapy [Time frame: From start of pharmacologic therapy to 8 weeks.]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• Pregnancy or breast feeding
• Presence of an ostomy
• 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
• Symptomatic stricture or stricture inducing bowel dilation (>3cm) as per local investigator.
• >4 very soft or liquid bowel movements per day when feeling well
• Diabetes mellitus requiring therapy with medication
• Known allergy to any ingredient in the Kate Farms formula.
• Unable to complete online surveys
• Unable to receive shipments of PEN formula.
• 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
• At time of screening, participant is taking both Prednisone and Budesonide
• Untreated C. difficile infection with the last 8 weeks

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT07356232 · 859860

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗