Completed

Nutrition Protocol for Crohn's Disease Flare with Immunologic Therapy

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What is being tested

IBD-AID diet combined with Kate Farms Peptide 1.5

+ IBD-AID diet

Dietary SupplementOther
Who is being recruted

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2023
See protocol details

Summary

Principal SponsorKate Farms Inc
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2023

Actual date on which the first participant was enrolled.

This study is focused on helping adults with Crohn's disease who are experiencing a flare-up and beginning new immunologic therapy. It aims to improve their nutrition by using a special diet called IBD-AID, combined with a plant-based protein supplement known as Kate Farms Peptide 1.5. The goal is to increase the intake of proteins, calories, and other important nutrients. By addressing nutritional needs during a Crohn's disease flare, this study hopes to support better overall health and enhance the effectiveness of the new treatment. Participants in the study will follow the IBD-AID diet and take the oral nutrition supplement, which is made from pea protein. The study will assess the impact of this dietary intervention on participants' nutritional status. To do this, researchers will measure changes in body composition, which provides a more detailed understanding of a person's nutritional health than just looking at weight or body mass index (BMI). This approach aims to provide a clearer picture of how well the intervention works in improving health outcomes for those with Crohn's disease.

Official TitleA Novel Partial-enteral Nutrition Protocol to Improve Nutrition Status of Adults Patients Experiencing a Crohn's Disease Flare and Starting New Immunologic Therapy. 
NCT07113431
Principal SponsorKate Farms Inc
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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
9 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Minnesota

Minneapolis, United StatesSee the location
CompletedOne Study Center