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

N/AActive Not RecruitingNCT06301477

Children's Hospital of Eastern Ontario45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Inflammatory Bowel Diseases Crohn Disease

Interventions

Resistant StarchOTHER

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

PlaceboOTHER

Placebo oral consumption of food-grade cornstarch

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

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

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

Secondary Outcomes

Change in intensification as measured by anti-TNFa dose escalation

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

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

Change in intensification as measured by anti-TNFa interval shortening

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

Data from ClinicalTrials.gov

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