Study Evaluating High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Levels Comparing Amino Acid-Based and Blenderized Diets Delivered by Gastrostomy Tube in Children

What this Trial Is About

Researchers are evaluating the effects of three different diets on gastric and salivary bile acid concentrations in children aged 5 to 21 years who use gastrostomy tubes for feeding. The study compares an amino acid-based formula, a low bile acid-binding blenderized diet, and a high bile acid-binding blenderized diet to understand differences in bile acid levels over a 4-hour period after feeding. Participants who usually receive amino acid-based formulas will continue with that diet, while those on blenderized feeds will be randomized to either the high or low bile acid-binding blenderized diet. During the study, participants will receive one bolus feed of their assigned dieteither an amino acid-based formula or one of the two blenderized dietsadministered through their gastrostomy tube. The diets being tested include commercial and proprietary blends with varying bile acid-binding properties. The study will measure bile acid concentrations at multiple time points within 4 hours after feeding. Participants who take acid suppression or motility medications must stop these at least 72 hours before the study. Participants will be monitored for gastric and salivary bile acid levels using tests conducted before and at intervals after the meal. Researchers will also assess correlations between bile acid concentrations and symptoms such as gastroesophageal reflux. The primary outcome is gastric bile acid concentration measured 4 hours post-feeding. The total participation period involves a single feeding and monitoring session lasting 4 hours. Safety and eligibility will be carefully assessed before participation.

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)