Resistant Starch
Resistant Starch for Inflammatory Bowel Disease
Children's Hospital of Eastern Ontario, Ottawa, Canada
Targeting 3 different conditionsResistant Starch +1 moreN/AWaitlist AvailableLed by David Mack, MD, FRCPCResearch Sponsored by Children's Hospital of Eastern OntarioEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upenrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months
Awards & highlights
Study Summary
This trial will study whether a specific type of resistant starch can help treat IBD by targeting the gut microbiome.
Eligible Conditions
- Inflammatory Bowel Disease
- Crohn's Disease
- Ulcerative Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compliance of resistant starch intake by patient report.
Compliance of resistant starch intake by product reconciliation.
Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis.
+2 moreSecondary outcome measures
Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease, the PUCAI and Partial Mayo Score for Ulcerative Colitis, and the PGA for both Crohn's Disease and Ulcerative Colitis.
Change in endoscopic disease activity measured during colonoscopies using the SES-CD for Crohn's Disease and the Mayo Endoscopic Sub Score and UCEIS for Ulcerative Colitis.
Change in histological scoring of acute and chronic inflammation collected through biopsies during colonoscopies and assessed using Naini and Cortina score for Crohn's disease and the Robarts Histopathological Index (RHI) for Ulcerative Colitis.
+5 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Resistant StarchActive Control1 Intervention
Once daily oral consumption of 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months
Group II: PlaceboPlacebo Group1 Intervention
Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months
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Who is running the clinical trial?
Children's Hospital of Eastern OntarioLead Sponsor
121 Previous Clinical Trials
54,906 Total Patients Enrolled
David Mack, MD, FRCPCPrincipal Investigator
Children's Hospital of Eastern Ontario1 Previous Clinical Trials
100 Total Patients Enrolled
Alain Stintzi, PhDPrincipal Investigator
University of Ottawa1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolment for this clinical trial ongoing?
"According to the clinical trials database, this research project is actively seeking participants. Initially published on August 25th 2020, it was last updated on July 19th 2022."
Answered by AI
Could I potentially qualify to take part in this scientific experiment?
"This clinical trial seeks 80 volunteers with ileocolitis aged between 5 and 17 years. To be eligible, applicants must demonstrate the capacity to comply with all necessary study procedures (e.g., stool sample collections) throughout its duration as well as provide their informed consent/assent for the collection of such samples."
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Is enrollment in this trial open to individuals over the age of 45?
"In order to meet the requirement for participation, individuals must be between 5 and 17 years of age."
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