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.
- EligibilityCriteria: 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. - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 16 Years - StdAgeList: Child