Recruiting

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 Supplement
Other
Who is being recruted

Crohn's Disease(CD)

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
Study ContactClinical Research Coordinator
Last updated: August 8, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2023Actual 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. 
Principal SponsorKate Farms Inc
Study ContactClinical Research Coordinator
Last updated: August 8, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Crohn's Disease(CD)
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
Placebo
Group II
Active Comparator
Study Objectives
Primary Objectives

Nutrient intake improvement assessed by 24-hour dietary recall from a combined intervention of a standard IBD-AID diet with an oral nutrition supplement drink (Kate Farms Peptide 1.5) compared to a standard diet alone without an oral nutrition supplement drink.
Secondary Objectives

Body composition measures assessed by bioimpedance spectroscopy (BIS).

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
Recruiting
University of MinnesotaMinneapolis, United StatesSee the location
Recruiting
One Study Center