NCT07303868

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)

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 2)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.

Conditions

• Feeding Difficulties
• Gastrostomy
• Aspiration

Interventions

Type	Name	Description
DRUG	Low bile acid binding blenderized diet	Low bile acid binding blenderized diet administered for 2 weeks
DRUG	High bile acid binding blenderized diet	High bile acid binding blenderized diet administered for 2 weeks

Timeline

• Start date: 2026-07-01
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Regulatory

• FDA-regulated drug study