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The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
5 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-01
Completion Date
2030-08
Last Updated
2025-12-26
Healthy Volunteers
No
Interventions
amino acid based formula (e.g. Elecare Jr)
We will administer one bolus of an amino acid based formula
low bile acid binding blenderized diet (e.g. Kate Farms)
We will administer one bolus of a low bile acid binding blenderized diet
high bile acid binding blenderized diet
We will administer one bolus of a high bile acid binding blenderized diet
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States