Crohn's Disease(CD)NCT07113431
Partial-enteral Nutrition Protocol for Crohn's Disease
A study testing IBD-AID diet combined with Kate Farms Peptide 1.5 and IBD-AID diet in people with Crohn's Disease(CD), run by Kate Farms Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease(CD)
- What is being tested?
- IBD-AID diet combined with Kate Farms Peptide 1.5 and IBD-AID diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
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)
- Being tested
- IBD-AID diet combined with Kate Farms Peptide 1.5, IBD-AID diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBD-AID diet combined with Kate Farms Peptide 1.5Dietary supplement
Combining standardized-IBD diet developed by the University of Minnesota (IBD-AID) with commercially available pea protein plant-based enteral nutrition formula (Kate Farms Peptide 1.5)
IBD-AID dietOther
Standardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID)
| Study group | Role | What they receive |
|---|---|---|
| IBD-AID diet | Placebo comparator | Not described Receives: Other: IBD-AID diet |
| IBD-AID Diet + Kate Farms Peptide 1.5 | Active comparator | Not described Receives: Dietary Supplement: IBD-AID diet combined with Kate Farms Peptide 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient intake
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.
Measured: 8 weeks
Secondary outcomes (1)
Body composition
Body composition measures assessed by bioimpedance spectroscopy (BIS).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2023
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease(CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kate Farms Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113431
- Sponsor's protocol ID
- UMN2023
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07113431
- Acronym / sponsor ID
- UMN2023
- Conditions
- Crohn's Disease(CD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kate Farms IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD-AID diet | Placebo comparator | Other: IBD-AID diet |
| IBD-AID Diet + Kate Farms Peptide 1.5 | Active comparator | Dietary Supplement: IBD-AID diet combined with Kate Farms Peptide 1.5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBD-AID diet combined with Kate Farms Peptide 1.5Combining standardized-IBD diet developed by the University of Minnesota (IBD-AID) with commercially available pea protein plant-based enteral nutrition formula (Kate Farms Peptide 1.5) | Dietary supplement | IBD-AID Diet + Kate Farms Peptide 1.5 |
| IBD-AID dietStandardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID) | Other | IBD-AID diet |
Primary outcome
Nutrient intake
Time frame: 8 weeks
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.
1 secondary outcome
Body composition
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBD-AID diet combined with Kate Farms Peptide 1.5 and IBD-AID diet in people with Crohn's Disease(CD), run by Kate Farms Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrient intake (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.