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Partial-enteral Nutrition Protocol for Crohn's Disease

NCT07113431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-09

No results posted yet for this study

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

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-10-24
Completion
2025-10-24

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07113431 on ClinicalTrials.gov