NCT07303738

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

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Feeding Difficulties
• Aspiration
• Gastrostomy

Interventions

Type	Name	Description
DRUG	amino acid based formula (e.g. Elecare Jr)	We will administer one bolus of an amino acid based formula
DRUG	low bile acid binding blenderized diet (e.g. Kate Farms)	We will administer one bolus of a low bile acid binding blenderized diet
DRUG	high bile acid binding blenderized diet	We will administer one bolus of a high bile acid binding blenderized diet

Timeline

• Start date: 2025-12-01
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study