Resistant Starch for Crohn's Disease
(PROMOTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special type of plant starch, known as Resistant Starch, can improve gut health in children with Crohn's Disease. The researchers seek to discover if this starch can increase certain beneficial bacteria that produce butyrate, a substance that supports gut health. Participants will consume either this resistant starch or a placebo (a look-alike with no active ingredient) daily for 48 weeks. Children with Crohn's Disease affecting specific gut areas and who are already on certain medications may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance gut health in children with Crohn's Disease.
Do I need to stop my current medications for the trial?
The trial requires participants to be on infliximab or adalimumab for Crohn's Disease and not to change their medical treatment for at least a month before and during the trial. So, you will need to continue your current medication if it's one of these.
What prior data suggests that this resistant starch is safe for humans?
Research has shown that resistant starch is generally safe for consumption. Studies have found it can improve gut health by reducing inflammation and alleviating symptoms of inflammatory bowel disease (IBD). Animal research also suggests it might aid in healing the gut lining.
In one study, consuming about 5 grams of resistant starch daily eased stomach issues over several weeks, with no serious side effects. Another study found that resistant potato starch could lower histamine levels in the blood, potentially helping with some allergies, without affecting the enzymes that break down histamine.
Overall, resistant starch appears safe for people, with no major negative effects reported.12345Why are researchers excited about this trial?
Unlike the standard treatments for Crohn's disease, which often include anti-inflammatory drugs, immunosuppressants, and biologics, resistant starch offers a unique approach by promoting gut health through dietary modification. Researchers are excited about resistant starch because it acts as a prebiotic, feeding beneficial gut bacteria and potentially reducing inflammation from the inside out. This method is non-invasive and based on optimizing the microbiome, which could lead to fewer side effects and a more natural way to manage the condition over time.
What evidence suggests that resistant starch might be an effective treatment for Crohn's disease?
Research has shown that resistant starch, which participants in this trial may receive, can aid people with Crohn's disease by enhancing gut health. Studies have found that it reduces gut damage, a sign of inflammation. Resistant starch also alters gut bacteria, increasing those that produce butyrate, a substance that supports gut health. It can also alleviate unusual bowel symptoms, common in Crohn's disease. These benefits make resistant starch a promising option for managing symptoms.12567
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either resistant starch or placebo for 48 weeks, with optimization at 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Resistant Starch
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Eastern Ontario
Lead Sponsor