protocolSection identificationModule nctId: NCT06301477, orgStudyIdInfo id: 23/109X, briefTitle: PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial, acronym: PROMOTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Eastern Ontario, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A single-center, randomized, placebo-controlled, double-blinded, pilot trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: The treating physician, study participants, and research coordinators and lab researchers will not have knowledge of the randomization codes and will be blinded as to study product allocation. Unblinding will occur only if necessary to ensure study participants safety. Only Dr. Mack (Co-PI) will request to break the blind for safety reasons. Once the blind is broken by Dr. Mack the patient will be discontinued from study product., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Resistant Starch, interventions name: Placebo, outcomesModule primaryOutcomes measure: Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis, primaryOutcomes measure: Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis, primaryOutcomes measure: Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis, secondaryOutcomes measure: Change in intensification as measured by anti-TNFa dose escalation, secondaryOutcomes measure: Change in intensification as measured by anti-TNFa interval shortening, secondaryOutcomes measure: Change in disease activity, secondaryOutcomes measure: Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples, secondaryOutcomes measure: Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples, secondaryOutcomes measure: Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire, secondaryOutcomes measure: Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire, secondaryOutcomes measure: Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital of Eastern Ontario, city: Ottawa, state: Ontario, zip: K1H 8L1, country: Canada, contacts name: David Mack, MD, FRCPC, role: CONTACT, phone: (613)737-7600, phoneExt: 2516, email: dmack@cheo.on.ca, contacts name: Ruth Singleton, RN, CCRP, role: CONTACT, phone: (613)737-7600, phoneExt: 4123, email: rsingleton@cheo.on.ca, contacts name: David Mack, MD, FRCPC, role: PRINCIPAL_INVESTIGATOR, contacts name: Alain Stintzi, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False