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Resistant Starch

Resistant Starch for Inflammatory Bowel Disease

N/A
Waitlist Available
Led By David Mack, MD, FRCPC
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
Existing Crohn's disease or ulcerative colitis diagnosis.
Be younger than 18 years old
Must not have
Requirement for antibiotic therapy >2 weeks duration.
Patients with previous intestinal surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
Awards & highlights

Summary

This trial will study whether a plant-based resistant starch can help treat inflammatory bowel disease by targeting the gut microbiome.

Who is the study for?
This trial is for pediatric patients with mild or in-remission Inflammatory Bowel Disease (IBD), including Crohn's and Ulcerative Colitis, who've had stable treatment for a month. Participants must be able to follow the study procedures like stool collections and not have diabetes, drug/alcohol dependence, recent antibiotics (>2 weeks), or other chronic diseases needing medication.
What is being tested?
The MEND Trial is testing whether a plant-based resistant starch tailored to individuals can improve gut health in kids with IBD by targeting the disease cause and altering their gut microbiome. It involves comparing this optimized starch against a placebo.
What are the potential side effects?
While specific side effects are not listed, resistant starch could potentially cause digestive discomfort such as bloating or gas. Allergic reactions may occur but are expected to be rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Crohn's disease or ulcerative colitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need antibiotics for more than 2 weeks.
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I have had surgery on my intestines before.
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I have been diagnosed with diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 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.
Secondary study objectives
Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.
Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.
Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Resistant StarchActive Control1 Intervention
Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months
Group II: PlaceboPlacebo Group1 Intervention
Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor
129 Previous Clinical Trials
60,355 Total Patients Enrolled
David Mack, MD, FRCPCPrincipal InvestigatorChildren's Hospital of Eastern Ontario
1 Previous Clinical Trials
80 Total Patients Enrolled
Alain Stintzi, PhDPrincipal InvestigatorUniversity of Ottawa
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Resistant Starch (Resistant Starch) Clinical Trial Eligibility Overview. Trial Name: NCT04520594 — N/A
Inflammatory Bowel Disease Research Study Groups: Resistant Starch, Placebo
Inflammatory Bowel Disease Clinical Trial 2023: Resistant Starch Highlights & Side Effects. Trial Name: NCT04520594 — N/A
Resistant Starch (Resistant Starch) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04520594 — N/A
~2 spots leftby Oct 2024
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