NCT07113431Completed
Partial-enteral Nutrition Protocol for Crohn's Disease
A Novel Partial-enteral Nutrition Protocol to Improve Nutrition Status of Adults Patients Experiencing a Crohn's Disease Flare and Starting New Immunologic Therapy.
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 24 Jul 2025
- Start date
- 1 Aug 2023
- Primary completion date
- 24 Oct 2025
- Lead sponsor
- Kate Farms Inc
- Diseases
- Crohn's disease
- NCT number
- NCT07113431
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Aug 2023 to the primary completion date, 24 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Diagnosis of short bowel syndrome
- High risk for development of refeeding syndrome
- Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices
Other
- 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
- In the opinion of the investigator would not complete the study procedures
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.