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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

Existing Crohn's disease or ulcerative colitis diagnosis.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with Crohn's disease or ulcerative colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.

Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.

Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.

Secondary outcome measures

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.

+4 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor

126 Previous Clinical Trials

55,382 Total Patients Enrolled

Alain Stintzi, PhDPrincipal InvestigatorUniversity of Ottawa

1 Previous Clinical Trials

80 Total Patients Enrolled

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for this clinical trial inclusive of those aged 30 or older?

"Potential participants in this clinical trial need to be aged between 5 and 17 years old, per the specified conditions for inclusion."

Answered by AI

Would I be a suitable participant for this research endeavor?

"This investigation seeks 100 minors between the ages of 5 and 17 that present with an inflammatory bowel disorder. In order to be considered, potential participants must demonstrate the capacity to abide by study protocol (e.g., providing stool samples) for its entirety, give consent/assent for sample collection, and remain in clinical remission or mild disease state (with wPCDAI of 0-39.5 for CD; PUCAI of 0-30 UC), without undergoing any changes in usual care treatment from before to during the research period."

Answered by AI

How many participants are currently enrolled in this trial?

"Affirmative. Details displayed on clinicaltrials.gov prove that this medical trial, which first appeared online on March 3rd 2021, is actively recruiting participants. The search for 100 patients has been narrowed to a single location."

Answered by AI

Are participants being recruited for this trial presently?

"Affirmative, the information displayed on clinicaltrials.gov indicates that this medical trial is currently in search of participants. It was initially posted to the database on March 3rd 2021 and has most recently been updated on July 19th 2022; 100 individuals are required at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

David Mack 2021. "OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04520594.

All > Inflammatory Bowel Disease > Crohns Disease