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

Conditions

• Crohn's Disease, Active

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Feb 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Partial enteral nutrition
  Participants will consume Kate Farms Peptide 1.5 for 60% of their calories for 8 weeks
• No Intervention: No partial enteral nutrition

Primary Outcome Measure

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

Locations (1)

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