[{"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":10,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":10,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"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",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":49,"type":50},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.",[54,55,56],"Feeding Difficulties","Gastrostomy","Aspiration",[58,59,60,61],"blenderized","bile acid","gastrostomy","aspiration","NOT_YET_RECRUITING","2025-12-23",{"date":65,"type":66},"2025-12-30","ACTUAL",{"date":68,"type":50},"2026-07",{"date":70,"type":50},"2030-08",{"name":5,"class":6}]