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Gut bacteria diet may extend Crohn's remission in children

NCT ID NCT06301477

Disease control Sponsor: Children's Hospital of Eastern Ontario Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a personalized diet supplement (a type of starch) can increase helpful gut bacteria in children with Crohn's disease. The goal is to see if this can help maintain remission and reduce the need for stronger medication. The study involves 45 children aged 8 to 16 who are already on anti-TNF therapy and have mild or inactive disease.

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

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

8 to 16 years

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: * Age between 8.0 to 16.9 years of age. * Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf. * Established Crohn's Disease (CD) diagnosis with the site of disease involving at least the terminal ileum or ascending colon. * CD is in clinical remission or with mild stable disease activity (weighted Pediatric Crohn's Disease Activity Index of 0 to 39.5). * Receiving infliximab or adalimumab anti-TNFa monoclonal antibody medication for treatment of CD. * No changes in medical treatment for the previous month and without anticipated changes for the next month. * Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study. Exclusion Criteria: * Allergy to RS or excipients. * Co-existing diagnosis with diabetes mellitus type 1. * Treatment with another investigational drug or intervention throughout the study. * Current illicit drug or alcohol dependence. * Inability or unwillingness of an individual or legal guardian to give written informed consent. * Other conditions requiring immunomodulating or biological medications. * Pregnancy. * Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

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

Crohn disease Inflammatory bowel diseases

Contacts and locations

Locations

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.