Clinical trial NCT06301477: PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial
Official title: PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Keywords: Resistant Starch
Microbiome
anti-TNF
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, randomized, placebo-controlled, double-blinded, pilot trial
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
measure: Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
measure: Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Secondary outcomes:
measure: Change in intensification as measured by anti-TNFa dose escalation
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Change in intensification as measured by anti-TNFa interval shortening
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Change in disease activity
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire
timeFrame: Baseline, 24 weeks, 48 weeks
measure: Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire
timeFrame: Baseline, 24 weeks, 48 weeks
measure: Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P
timeFrame: Baseline, 24 weeks, 48 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
References: