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Partial-enteral Nutrition Protocol for Crohn's Disease

Description

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)
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Related Conditions:

Crohn's Disease(CD)

Study Overview

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Study Details

Study overview

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.

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

Partial-enteral Nutrition Protocol for Crohn's Disease

Condition
Crohn's Disease(CD)
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kate Farms Inc,

Study Record Dates

2025-11-01