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 Ontario

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


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
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months for reporting.

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 more
Secondary 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 more

Trial 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

Find a site

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 Ontario
1 Previous Clinical Trials
100 Total Patients Enrolled
Alain Stintzi, PhDPrincipal Investigator
University of Ottawa
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Resistant Starch (Resistant Starch) Clinical Trial Eligibility Overview. Trial Name: NCT04522271 — N/A
Inflammatory Bowel Disease Research Study Groups: Resistant Starch, Placebo
Inflammatory Bowel Disease Clinical Trial 2023: Resistant Starch Highlights & Side Effects. Trial Name: NCT04522271 — N/A
Resistant Starch (Resistant Starch) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04522271 — N/A

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."

Answered by AI

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."

Answered by AI
~20 spots leftby Oct 2024