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OpenTrials
Active, Not Recruiting

NCT Number: NCT04520594

OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

The purpose of the study is to determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
  • Enrolled in the main parent study.
  • Existing Crohn's disease or ulcerative colitis diagnosis.
  • In clinical remission or with mild disease (wPCDAI of 0-39.5 for CD; PUCAI of 0-30 for UC) with no changes in standard of care treatment for the previous month and without anticipated changes for the next month.
  • Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
  • Willing to provide consent/assent for the collection of stool samples.

Exclusion criteria

  • Allergy to resistant starch or excipients.
  • Co-existing diagnosis with diabetes mellitus.
  • Treatment with another investigational drug or intervention throughout the study.
  • Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of an individual or legal guardian to give written informed consent.
  • Concomitant chronic disease requiring medications.
  • Requirement for antibiotic therapy >2 weeks duration.
  • Participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the RapidAIM evaluation following the initial stool sample collection.
  • Patients with previous intestinal surgery.

Treatment and study plan

Resistant starch

Other

7.5 g resistant starch/m2 oral consumption

Placebo

Other

Placebo oral consumption of food-grade cornstarch

Primary outcomes

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

    Time frame: 6 ± 1 months

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

    Time frame: 12 ± 2 months

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

    Time frame: 6 ± 1 months and 12 ± 2 months

Secondary outcomes

  1. Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.

    Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

    The IBD disability index consists of 28 questions and a higher overall score is indicative of greater disability.

  2. Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.

    Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

    The IMPACT III questionnaire (a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life. The IMPACT III-P Questionnaire is to be completed by the caregiver/guardian with a higher score also representing a higher quality of life.

  3. Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.

    Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months, 9 ± 1 months, and 12 ± 2 months

  4. Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease.

    Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

    Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) ranges from 0 to 125 points (<12.5 = remission, 12.5 to 40.0 = mild, >40.0 = moderate, >57.5 = severe).

  5. Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.

    Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

    The Pediatric Ulcerative Colitis Activity Index (PUCAI) ranges from 0 to 85 points (<10 = remission, 10 to 34 = mild, 35 to 64= moderate, >65 = severe).

  6. Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.

    Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

    The Partial Mayo Score ranges from 0 to 9 points (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, 7 to 9 = severe).

  7. Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.

    Time frame: Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months

    The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Aug 20, 2020
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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