Partial-enteral Nutrition Protocol for Crohn's Disease

Kate Farms

Status: Completed

Conditions: Crohn's Disease(CD)

Treatments: Other: IBD-AID diet; Dietary Supplement: IBD-AID diet combined with Kate Farms Peptide 1.5

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07113431

UMN2023

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

IBD-AID diet

Placebo Comparator group

Treatment:

Other: IBD-AID diet

IBD-AID Diet + Kate Farms Peptide 1.5

Active Comparator group

Treatment:

Dietary Supplement: IBD-AID diet combined with Kate Farms Peptide 1.5