Could a special starch heal the gut in kids with IBD?

NCT ID NCT04522271

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a plant-based resistant starch, tailored to each child's gut bacteria, can improve gut health in 80 children with Crohn's disease or ulcerative colitis. Participants will take the starch or a placebo for a period, and researchers will measure changes in gut bacteria and inflammation. The goal is to see if this simple dietary addition can help manage inflammatory bowel disease.

What this could mean

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

Active substance
plant-based resistant starch
What this could lead to
If it works, this could point toward a dietary approach to support gut health and reduce inflammation in children with inflammatory bowel disease.
What could go wrong
This is a small, early pilot study with only 80 participants. It tests a dietary supplement, not a drug, so any benefits may be modest and may not apply to all patients.

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 80 people

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

Started

Aug 2020

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. * New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy. * Clinically responsive to induction medical therapy at enrollment (Crohn's Disease participants with a weighted pediatric Crohn's Disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points). * 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. * Requirement for antibiotic therapy as part of standard Crohn's Disease therapy (i.e. those patients with penetrating disease as manifested by intra-abdominal abscess or perianal abscess). * Requirement of oral antibiotics for other conditions (e.g. acne). * Participant's microbiota does not produce butyrate in response to any of the assembled panel of resistant starch as measured through the Rapid Assay of an Individual's Microbiome (RapidAIM) evaluation following enrollment. * Requirement of therapy other than oral corticosteroid / aminosalicylates for induction therapy. * Patients diagnosed with Inflammatory Bowel Disease-Unclassified. * Refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for Crohn's Disease standard of care.

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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

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

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