Completed

NCT Number: NCT07113431

Partial-enteral Nutrition Protocol for Crohn's Disease

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.

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Key information

Conditions

Crohn's Disease(CD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBD-AID diet combined with Kate Farms Peptide 1.5

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)

IBD-AID diet

Other

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

Primary outcomes

Nutrient intake

Time frame: 8 weeks

Nutrient intake improvement assessed by 24-hour dietary recall from a combined intervention of a standard IBD-AID diet with an oral nutrition supplement drink (Kate Farms Peptide 1.5) compared to a standard diet alone without an oral nutrition supplement drink.

Secondary outcomes

Body composition

Time frame: 8 weeks

Body composition measures assessed by bioimpedance spectroscopy (BIS).

Sponsors and collaborators

Lead sponsor

Kate Farms Inc

Industry

Collaborators

University of Minnesota

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Aug 8, 2025
Registry last updated: Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.