Resistant Starch for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

Overseen byDavid Mack, MD, FRCPC

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Hospital of Eastern Ontario

Trial Summary

What is the purpose of this trial?

The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.

Research Team

Alain Stintzi, PhD

Principal Investigator

University of Ottawa

David Mack, MD, FRCPC

Principal Investigator

Children's Hospital of Eastern Ontario

Eligibility Criteria

This trial is for kids with new mild/moderate ulcerative colitis or moderate/severe Crohn's Disease who've started treatment with steroids or aminosalicylates. They must be responding to therapy and able to follow the study rules, like giving stool samples. Kids can't join if they're dependent on drugs/alcohol, allergic to resistant starch, taking other experimental treatments, unwilling to consent, don’t respond to starch in tests, need antibiotics for Crohn's complications or have diabetes.

Inclusion Criteria

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

I can make my own medical decisions or have someone who can.

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Exclusion Criteria

Inability or unwillingness of an individual or legal guardian to give written informed consent

I need treatment beyond oral steroids or aminosalicylates.

Treatment with another investigational drug or intervention throughout the study

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Treatment Details

Interventions

Placebo (Other)
Resistant Starch (Resistant Starch)

Trial OverviewThe study is testing whether a plant-based resistant starch tailored for each child can help treat inflammatory bowel disease by improving gut health. Participants will either get this special starch or a placebo (a harmless substance that has no effect). The goal is to see if the starch makes their guts healthier.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Resistant StarchActive Control1 Intervention

Once daily oral consumption of 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months

Group II: PlaceboPlacebo Group1 Intervention

Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months