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NCT Number: NCT06301477

PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial

To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Inflammatory Bowel Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

8 year–16 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

  • Age between 8.0 to 16.9 years of age.
  • Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
  • Established Crohn's Disease (CD) diagnosis with the site of disease involving at least the terminal ileum or ascending colon.
  • CD is in clinical remission or with mild stable disease activity (weighted Pediatric Crohn's Disease Activity Index of 0 to 39.5).
  • Receiving infliximab or adalimumab anti-TNFa monoclonal antibody medication for treatment of CD.
  • No changes in medical treatment for the previous month and without anticipated changes for the next month.
  • Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study.

Exclusion criteria

  • Allergy to RS or excipients.
  • Co-existing diagnosis with diabetes mellitus type 1.
  • Treatment with another investigational drug or intervention throughout the study.
  • Current illicit drug or alcohol dependence.
  • Inability or unwillingness of an individual or legal guardian to give written informed consent.
  • Other conditions requiring immunomodulating or biological medications.
  • Pregnancy.
  • Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay.

Treatment and study plan

Resistant starch

Other

7.5g/m2 or 5.0g/m2 (body surface area) resistant starch oral consumption

Placebo

Other

Placebo oral consumption of food-grade cornstarch

Primary outcomes

  1. Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.

    Measures of restoration and sustainment of butyrate production by using metaproteomic/transcription to assess the expression of enzymes invovled in butyrate production

  2. Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.

    Measures of restoration and sustainment of butyrate production by using metabolomics analysis to assess production of short-chain-fatty acids including butyrate.

  3. Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.

    Measures of restoration and sustainment of butyrate production by metagenomics/16s analysis to assess increases in butyrate producers

Secondary outcomes

  1. Change in intensification as measured by anti-TNFa dose escalation

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

    To help contextualize the anti-TNFa dose escalation (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded

  2. Change in intensification as measured by anti-TNFa interval shortening

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

    To help contextualize the anti-TNFa interval shortening (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded

  3. Change in disease activity

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

    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).

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

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

    Measure of fecal calprotectin

  5. Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples

    Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

    Measure of c-reactive protein

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

    Time frame: Baseline, 24 weeks, 48 weeks

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

  7. Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire

    Time frame: Baseline, 24 weeks, 48 weeks

    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.

  8. Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P

    Time frame: Baseline, 24 weeks, 48 weeks

    The IMPACT III-P 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Registry information

Acronym: PROMOTE

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Mar 8, 2024
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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