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Resistant Starch

Resistant Starch for Inflammatory Bowel Disease

N/A

Waitlist Available

Led By Alain Stintzi, PhD

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

Clinically responsive to induction medical therapy at enrollment (Crohn's Disease participants with a weighted pediatric Crohn's Disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points)

New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy

Timeline

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

Awards & highlights

Study Summary

This trial will study whether a specific type of resistant starch can help treat IBD by targeting the gut microbiome.

Who is the study for?

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.Check my eligibility

What is being tested?

The study is testing whether a plant-based resistant starch tailored for each child can help treat inflammatory bowel disease by improving gut health. Participants will either get this special starch or a placebo (a harmless substance that has no effect). The goal is to see if the starch makes their guts healthier.See study design

What are the potential side effects?

Since resistant starch comes from plants and acts as food for good bacteria in the gut, it’s generally safe. However, some kids might experience bloating or gas initially as their bodies adjust.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Crohn's Disease or ulcerative colitis symptoms improved significantly after initial treatment.

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I have been diagnosed with ulcerative colitis or Crohn's Disease and started treatment after my colonoscopy.

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor

126 Previous Clinical Trials

55,402 Total Patients Enrolled

Alain Stintzi, PhDPrincipal InvestigatorUniversity of Ottawa

1 Previous Clinical Trials

100 Total Patients Enrolled

David Mack, MD, FRCPCPrincipal InvestigatorChildren's Hospital of Eastern Ontario

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