RECRUITING

Partial-enteral Nutrition Protocol for Crohn's Disease

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Conditions

Crohn's Disease(CD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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.

Quick Facts

Study Start:2023-08-01
Study Completion:2025-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07113431

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Moderate to severe CD as defined by physician and starting new biologic therapy
  2. * Able and willing to complete the study procedures
  3. * Age \> 18
  4. * Able to comply with study measures in the opinion of the investigator
  1. * Diagnosis of short bowel syndrome
  2. * Presence of ileostomy or colostomy
  3. * Presence of a pacemaker or any electronic implantable device
  4. * Use of pre or probiotic supplements within 14 days of randomization
  5. * High risk for development of refeeding syndrome
  6. * In the opinion of the investigator would not complete the study procedures
  7. * Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices
  8. * 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
  9. * 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

Contacts and Locations

Study Contact

Clinical Research Coordinator
CONTACT
(612) 301-8294
chen8124@umn.edu
Co-Investigator
CONTACT
612-301-1625
teige027@umn.edu

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Kate Farms Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2025-11-01

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2025-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn's Disease(CD)