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Could a special starch help calm Crohn's and colitis?

NCT ID NCT04520594

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

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 plant-based starch, tailored to each child's needs, can help restore a healthier gut microbiome in children with inflammatory bowel disease (Crohn's or colitis). About 100 children with mild disease or in remission will receive the starch for 6 months. The goal is to see if it boosts butyrate production, a sign of gut health, and improves quality of life.

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 100 people

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

Started

Mar 2021

Expected to finish

Dec 2026

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

5 to 17 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: * Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf. * Enrolled in the main parent study. * Existing Crohn's disease or ulcerative colitis diagnosis. * In clinical remission or with mild disease (wPCDAI of 0-39.5 for CD; PUCAI of 0-30 for UC) with no changes in standard of care treatment for the previous month and without anticipated changes for the next month. * Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study. * Willing to provide consent/assent for the collection of stool samples. Exclusion Criteria: * Allergy to resistant starch or excipients. * Co-existing diagnosis with diabetes mellitus. * Treatment with another investigational drug or intervention throughout the study. * Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Inability or unwillingness of an individual or legal guardian to give written informed consent. * Concomitant chronic disease requiring medications. * Requirement for antibiotic therapy \>2 weeks duration. * Participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the RapidAIM evaluation following the initial stool sample collection. * Patients with previous intestinal surgery.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Crohn disease Inflammatory bowel diseases Ulcerative colitis

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.