NCT07113431

Partial-enteral Nutrition Protocol for Crohn's Disease

A Novel Partial-enteral Nutrition Protocol to Improve Nutrition Status of Adults Patients Experiencing a Crohn's Disease Flare and Starting New Immunologic Therapy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kate Farms Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A novel dietary intervention combining a standardized IBD diet (IBD-AID) with supplementation from a pea protein plant-based oral nutrition supplement (ONS) (Kate Farms Peptide 1.5) to improve protein, calorie, and nutrient intake in adult patients experiencing a Crohn's disease flare starting new immunologic therapy. Additionally, this study will include objective measures of body composition to improve nutrition status assessment and provide a more sensitive measure of intervention efficacy compared to anthropometric measures of body weight or BMI.

Conditions

• Crohn's Disease(CD)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	IBD-AID diet combined with Kate Farms Peptide 1.5	Combining standardized-IBD diet developed by the University of Minnesota (IBD-AID) with commercially available pea protein plant-based enteral nutrition formula (Kate Farms Peptide 1.5)
OTHER	IBD-AID diet	Standardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID)

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-10-24
• Completion: 2025-10-24
• First posted: 2025-08-08
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States