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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

Awards & highlights

PROMOTE Trial 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.Check my eligibility

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.See study design

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.

PROMOTE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

PROMOTE 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

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor

126 Previous Clinical Trials

55,437 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals who can participate in this medical research study?

"Patients aged between 8 and 16 diagnosed with Crohn's disease are eligible to participate in this trial, which has a capacity for enrolling 45 participants."

Answered by AI

Are individuals currently eligible to apply for participation in this ongoing medical study?

"As per the details on clinicaltrials.gov, this particular research investigation is not in search of participants currently. It was initially presented on 6th January 2024 and last modified on 3rd February 2024. Although recruitment is paused for now, there are a total of 346 ongoing studies actively seeking enrollees at present."

Answered by AI

Can individuals younger than 20 years old participate in this research study?

"Patients eligible for participation in this research must be between 8 and 16 years old. Among the registered clinical trials, there are 84 studies focusing on individuals under 18 and 270 targeting those over 65 years of age."

Answered by AI

What are the primary goals and objectives of this medical study?

"The main objective of this investigation, spanning over a period from Baseline to 48 weeks and involving assessments at 12-week intervals, is to quantify butyrate production through the evaluation of enzyme expression using metaproteomic/transcriptomic analysis. Secondary goals consist of monitoring changes in treatment intensity by tracking anti-TNFa dosage adjustments; collecting data on prescribed type and amount of anti-TNFa drugs, alterations in dosing schedules, serum levels of trough drug concentration, fluctuations in body weight, rationales behind dose modifications; as well as observing shifts in disease activity measured by Weighted Pediatric Crohn's disease Activity Index (wPC"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial

David Mack 2024. "PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06301477.

All > Inflammatory Bowel Disease > Crohns Disease