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 3)

NCT06913621 NOT_YET_RECRUITING

Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.

Details

Lead sponsor	Boston Children's Hospital
Status	NOT_YET_RECRUITING
Enrolment	138
Start date	2026-07
Completion	2030-08

Conditions

• Feeding Difficulties
• Gastrostomy
• Aspiration

Interventions

• amino acid formula
• low bile acid binding blenderized diet
• high bile acid binding blenderized diet

Primary outcomes

• total hospitalization and emergency room visits rates — 6 months
  total hospitalization and emergency room visits rates between participants receiving H-BBB and those receiving L-BBB or an amino acid-based formula