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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
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 moreTrial 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
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Who is running the clinical trial?
Children's Hospital of Eastern OntarioLead Sponsor
129 Previous Clinical Trials
60,410 Total Patients Enrolled