Resistant Starch for Inflammatory Bowel Disease
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are already on oral corticosteroids or aminosalicylates for induction therapy. If you need antibiotics for other conditions, you may not be eligible to participate.
What data supports the effectiveness of the treatment Resistant Starch for Inflammatory Bowel Disease?
Research suggests that resistant starch (RS) can improve colonic health by being fermented into short-chain fatty acids like butyrate, which is beneficial for the colon. Additionally, RS has been shown to have mild laxative effects and can increase stool weight, which may help manage symptoms in conditions like inflammatory bowel disease.12345
Is resistant starch safe for humans?
Resistant starch is generally safe for humans and has been shown to have mild laxative effects, increasing stool weight and frequency. It is digested in the large intestine and can increase the production of beneficial short-chain fatty acids, although some people may have difficulty breaking it down.35678
How does the treatment Resistant Starch differ from other treatments for Inflammatory Bowel Disease?
Resistant Starch is unique because it is not digested in the small intestine and is fermented in the colon to produce short-chain fatty acids, which can benefit gut health. This fermentation process may alter the gut microbiome and improve colonic health, offering a different approach compared to traditional treatments that often focus on reducing inflammation directly.246910
What is the purpose of this trial?
The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.
Research Team
Alain Stintzi, PhD
Principal Investigator
University of Ottawa
David Mack, MD, FRCPC
Principal Investigator
Children's Hospital of Eastern Ontario
Eligibility Criteria
This trial is for kids with new mild/moderate ulcerative colitis or moderate/severe Crohn's Disease who've started treatment with steroids or aminosalicylates. They must be responding to therapy and able to follow the study rules, like giving stool samples. Kids can't join if they're dependent on drugs/alcohol, allergic to resistant starch, taking other experimental treatments, unwilling to consent, don’t respond to starch in tests, need antibiotics for Crohn's complications or have diabetes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either resistant starch or placebo daily for approximately 5 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Resistant Starch
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Eastern Ontario
Lead Sponsor