Partial-enteral Nutrition Protocol for Crohn's Disease

NCT ID: NCT07113431

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-10-24

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBD-AID diet

Group Type: PLACEBO_COMPARATOR

IBD-AID diet

Intervention Type: OTHER

Standardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID)

IBD-AID Diet + Kate Farms Peptide 1.5

Group Type: ACTIVE_COMPARATOR

IBD-AID diet combined with Kate Farms Peptide 1.5

Intervention Type: DIETARY_SUPPLEMENT

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)

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

IBD-AID diet

Standardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Moderate to severe CD as defined by physician and starting new biologic therapy
• Able and willing to complete the study procedures
• Age > 18
• Able to comply with study measures in the opinion of the investigator

Exclusion Criteria

• Diagnosis of short bowel syndrome
• Presence of ileostomy or colostomy
• Presence of a pacemaker or any electronic implantable device
• Use of pre or probiotic supplements within 14 days of randomization
• High risk for development of refeeding syndrome
• In the opinion of the investigator would not complete the study procedures
• Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices
• Pregnant Patients: while the use of bioimpedance technology in pregnant patients has been shown to have no adverse effects, it has yet to be clinically validated for use with that population group
• Serious, concomitant illness that, in the opinion of the investigator would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Kate Farms Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

UMN2023

Identifier Type: -

Identifier Source: org_study_id