Could a special starch heal the gut in kids with IBD?
NCT ID NCT04522271
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
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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