[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616304":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":34,"collaborators":23,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":23,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":23,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":64,"whyStopped":23,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":23},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low bile binding then high bile binding blenderized diets","EXPERIMENTAL","2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets",[13,14],"Drug: Low bile acid binding blenderized diet","Drug: High bile acid binding blenderized diet",{"label":16,"type":10,"description":17,"interventionNames":18},"High bile binding then low bile binding blenderized diets","2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"amino acid-based formula","NO_INTERVENTION","Observational arm",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DRUG","Low bile acid binding blenderized diet","Low bile acid binding blenderized diet administered for 2 weeks",[16,9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"High bile acid binding blenderized diet","High bile acid binding blenderized diet administered for 2 weeks",[16,9],{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Rachel Rosen","Director, Aerodigestive Center","100616304","phase-4-the-use-of-high-bile-binding-foods-to-reduce-upper-gastrointestinal-bile-acid-concentrations-aim-2-100616304",false,"NCT07303868","The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)","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 2)","Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria\n\n* receive at least 80% of their nutritional needs via gastrostomy\n* receive blenderized feeds or will start receiving blenderized feeds\n* have no known allergies to ingredients in blenderized feeds;\n* receive their bolus feeds within 30 minutes or less\n* can receive their feeds by syringe push Exclusion criteria\n* have undergone anti-reflux surgery\n* receive post-pyloric feeds\n* are allergic to any component of the administered diets\n* cannot receive their gastrostomy feeds over 30 minutes\n* require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).\n\nPediatric patients ages 5 to 21 in the observational arm Inclusion\n\n* receive at least 80% of their nutritional needs via gastrostomy\n* are taking an amino acid formula\n* have not undergone antireflux surgery Exclusion\n* have undergone anti-reflux surgery\n* receive post-pyloric feeds\n* are not receiving an amino acid-based formula.","ALL","5 Years","21 Years",{"count":49,"type":50},66,"ESTIMATED","INTERVENTIONAL",[53],"PHASE4","Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.",[56,57,58],"Feeding Difficulties","Gastrostomy","Aspiration",[60,61,62,63],"blenderized","bile acid","gastrostomy","aspiration","NOT_YET_RECRUITING","2025-12-23",{"date":67,"type":68},"2025-12-26","ACTUAL",{"date":70,"type":50},"2026-07",{"date":72,"type":50},"2030-08",{"name":5,"class":6}]