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 1)
Boston Children's Hospital
Summary
We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe. Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.
Eligibility
- Age range
- 5–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * receive at least 80% of their nutritional needs by gastrostomy * receive either an amino acid-based formula, an International Dysphagia Diet Standardization Initiative level 4 commercial blend, or a home blend * can receive bolus feeds of 240 cc within 30 minutes or less Exclusion Criteria: * have received a fundoplication * receive post-pyloric feeds * require medication/flush administration during the four-hour study period * are allergic to any component of the study diets. To participate in this study, if patients are taking acid suppression or motility medication…
Interventions
- Drugamino acid based formula (e.g. Elecare Jr)
We will administer one bolus of an amino acid based formula
- Druglow bile acid binding blenderized diet (e.g. Kate Farms)
We will administer one bolus of a low bile acid binding blenderized diet
- Drughigh bile acid binding blenderized diet
We will administer one bolus of a high bile acid binding blenderized diet
Location
- Boston Children's HospitalBoston, Massachusetts