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 to 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 pediatric patients with mild or in-remission Inflammatory Bowel Disease (IBD), including Crohn's and Ulcerative Colitis, who've had stable treatment for a month. Participants must be able to follow the study procedures like stool collections and not have diabetes, drug/alcohol dependence, recent antibiotics (>2 weeks), or other chronic diseases needing medication.

Inclusion Criteria

Willing to provide consent/assent for the collection of stool samples.

I have been diagnosed with Crohn's disease or ulcerative colitis.

My Crohn's disease or ulcerative colitis is in remission or mild, with stable treatment for the last month.

See 3 more

Exclusion Criteria

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.

Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

You are allergic to resistant starch or other substances used in the study.

See 6 more

Treatment Details

Interventions

Placebo (Other)
Resistant Starch (Resistant Starch)

Trial OverviewThe MEND Trial is testing whether a plant-based resistant starch tailored to individuals can improve gut health in kids with IBD by targeting the disease cause and altering their gut microbiome. It involves comparing this optimized starch against a placebo.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Resistant StarchActive Control1 Intervention

Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months

Group II: PlaceboPlacebo Group1 Intervention

Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months