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

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 45

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis;Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis;Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis

Secondary Outcome Measures

Name	Time	Method
Change in intensification as measured by anti-TNFa dose escalation;Change in intensification as measured by anti-TNFa interval shortening;Change in disease activity;Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples;Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples;Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire;Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire;Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P