Resistant Starch for Crohn's Disease
(PROMOTE Trial)

Recruiting in Palo Alto (17 mi)

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?To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.

Eligibility Criteria

This trial is for children with Crohn's Disease, a type of Inflammatory Bowel Disease. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and may be required to have a diagnosis of Crohn's Disease.

Inclusion Criteria

Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study

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

I am between 8 and 16 years old.

+4 more

Exclusion Criteria

Current illicit drug or alcohol dependence

Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay

I am unable or unwilling to sign the consent form.

+5 more

Participant Groups

The PROMOTE Trial is testing if a special plant-based resistant starch can increase good microbes in the gut that help reduce inflammation when given alongside standard anti-TNFα therapy for Crohn's Disease in children.

2Treatment groups

Active Control

Placebo Group

Group I: Resistant StarchActive Control1 Intervention

Once daily oral consumption of either 7.5g/m2 or 5.0g/m2 (body surface area) of a resistant starch for 48 weeks that is individually optimized at 24 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Once daily oral consumption of a readily digestible food-grade cornstarch that resembles the study product in appearance, smell and taste for 48 weeks