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Pea protein drink may help Crohn's patients during Flare-Ups

NCT ID NCT07113431

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study tested a dietary plan combining a special diet for inflammatory bowel disease (IBD-AID) with a pea protein drink (Kate Farms Peptide 1.5) in 20 adults experiencing a Crohn's disease flare and starting new immunologic therapy. The goal was to see if this approach improves nutrient intake and body composition compared to the diet alone. The study measured dietary recall and body composition using bioimpedance spectroscopy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pea protein plant-based oral nutrition supplement (Kate Farms Peptide 1.5) combined with a standardized IBD diet
What this could lead to
If successful, this dietary approach could help improve nutrition and body composition during Crohn's flares, potentially supporting better outcomes with new immunologic therapy.
What could go wrong
This is a small, completed trial with only 20 participants, so results may not apply broadly. The intervention is dietary and may not significantly alter disease course.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Aug 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States