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)

NCT07303738 Phase 4 RECRUITING

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.

Details

Lead sponsor	Boston Children's Hospital
Phase	Phase 4
Status	RECRUITING
Enrolment	60
Start date	2025-12-01
Completion	2030-08

Conditions

• Feeding Difficulties
• Aspiration
• Gastrostomy

Interventions

• amino acid based formula (e.g. Elecare Jr)
• low bile acid binding blenderized diet (e.g. Kate Farms)
• high bile acid binding blenderized diet

Primary outcomes

• Gastric bile acid concentration — 4 hours
  Mean difference in gastric bile acid concentrations between start of feed and four hours following feed

Countries

United States