Partial-enteral Nutrition Protocol for Crohn's Disease

  • STATUS
    Recruiting
  • days left to enroll
    41
  • participants needed
    20
  • sponsor
    Kate Farms Inc
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Updated on 13 August 2025
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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.

Details
Condition Crohn's Disease(CD)
Age 18years or above
Clinical Study IdentifierNCT07113431
SponsorKate Farms Inc
Last Modified on13 August 2025

Eligibility

 Yes No Not Sure

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
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