[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586303":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":35,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":10},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,13,17],{"label":9,"type":10,"description":10,"interventionNames":11},"amino acid-based formula",null,[12],"Drug: amino acid formula",{"label":14,"type":10,"description":10,"interventionNames":15},"Low bile binding blenderized diet",[16],"Drug: low bile acid binding blenderized diet",{"label":18,"type":10,"description":10,"interventionNames":19},"High bile binding blenderized diet",[20],"Drug: high bile acid binding blenderized diet",[22,27,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DRUG","amino acid formula","amino acid formula for 6 months",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"low bile acid binding blenderized diet","low bile acid binding blenderized diet for 6 months",[14],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"high bile acid binding blenderized diet","high bile acid binding blenderized diet for 6 months",[18],{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Rachel Rosen","Director, Aerodigestive Center","100586303","the-use-of-high-bile-binding-foods-to-reduce-upper-gastrointestinal-bile-acid-concentrations-aim-3-100586303",false,"NCT06913621","The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)","The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations: A Novel Intervention for Children at Risk for Aspiration-Associated Complications (Aim 3)","Inclusion Criteria:\n\n* receive at least 80% of their nutritional needs via gastrostomy\n* receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula\n* receive their bolus feeds within 30 minutes or less.\n\nExclusion Criteria:\n\n* have undergone anti-reflux surger\n* receive post-pyloric feeds\n* receive regular daily prophylactic antibiotics.","ALL","5 Years","21 Years",{"count":50,"type":51},138,"ESTIMATED","OBSERVATIONAL","Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.",[55,56,57],"Feeding Difficulties","Gastrostomy","Aspiration",[59,60,61,62],"blenderized","bile acid","gastrostomy","aspiration","NOT_YET_RECRUITING","2025-12-23",{"date":66,"type":67},"2025-12-30","ACTUAL",{"date":69,"type":51},"2026-07",{"date":71,"type":51},"2030-08",{"name":5,"class":6}]