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

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.

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.