Resistant Starch for Crohn's Disease (PROMOTE Trial)

N/A

Waitlist Available

Research Sponsored by Children's Hospital of Eastern Ontario

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Summary

This trial aims to see if a special type of starch from plants can increase the amount of beneficial bacteria in the gut that produce a substance called butyrate.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since specific side effects are not listed, they might include typical reactions to dietary supplements such as digestive discomfort or changes in bowel habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis

Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis

Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis

Secondary study objectives

Change in disease activity

Change in intensification as measured by anti-TNFa dose escalation

Change in intensification as measured by anti-TNFa interval shortening

+5 more

Trial Design

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

Do I qualify?Apply below to find out