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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

Must not have

Refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for Crohn's Disease standard of care.

Participant's microbiota does not produce butyrate in response to any of the assembled panel of resistant starch as measured through the Rapid Assay of an Individual's Microbiome (RapidAIM) evaluation following enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment, 5 ± 1 months, and 12 ± 2 months

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I refuse to have a follow-up colonoscopy for my Crohn's Disease.

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My gut bacteria do not produce butyrate when I eat certain starches, as tested after joining.

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I have been diagnosed with an unspecified type of Inflammatory Bowel Disease.

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I have been diagnosed with diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment, 5 ± 1 months, and 12 ± 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment, 5 ± 1 months, and 12 ± 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 5 ± 1 months, and 12 ± 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percentage of eligible inflammatory bowel disease (IBD) patients who will enter a resistant starch-based ingestion trial.

Secondary study objectives

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.

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