NCT07356232

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Crohn's Disease, Active

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2026-01-21
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States