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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrostomy; Aspiration; Feeding Difficulties
• Intervention / Treatment: Drug: Low bile acid binding blenderized diet; Drug: High bile acid binding blenderized diet

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria

• receive at least 80% of their nutritional needs via gastrostomy
• receive blenderized feeds or will start receiving blenderized feeds
• have no known allergies to ingredients in blenderized feeds;
• receive their bolus feeds within 30 minutes or less
• can receive their feeds by syringe push Exclusion criteria
• have undergone anti-reflux surgery
• receive post-pyloric feeds
• are allergic to any component of the administered diets
• cannot receive their gastrostomy feeds over 30 minutes
• require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).

Pediatric patients ages 5 to 21 in the observational arm Inclusion

• receive at least 80% of their nutritional needs via gastrostomy
• are taking an amino acid formula
• have not undergone antireflux surgery Exclusion
• have undergone anti-reflux surgery
• receive post-pyloric feeds
• are not receiving an amino acid-based formula.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low bile binding then high bile binding blenderized diets; 2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets	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
Experimental: High bile binding then low bile binding blenderized diets; 2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets	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
No Intervention: amino acid-based formula; Observational arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric bile acid concentration	differences in total gastric bile acid concentrations at the end of each diet period	after 2 weeks on each of 2 diets (cross-over design)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric bile acid concentration	changes in gastric bile acid composition (e.g., change in the proportion of gastric conjugated:unconjugated bile acid) between diet periods	after 2 weeks on each of 2 diets (cross-over design)
Symptom scores	changes in symptoms over the two weeks between diet periods	after 2 weeks on each of 2 diets (cross-over design)
Salivary and stool bile acid concentrations	changes in the total salivary and stool BA concentrations between diet periods;	after 2 weeks on each of 2 diets (cross-over design)
Serum complement 4 (C4)	changes in serum C4 between diet periods	after 2 weeks on each of 2 diets (cross-over design)
gastric, salivary, and stool bile acid	changes in gastric, salivary, and stool bile acid over time between the high bile binding blend, low bile binding blend and amino acid-based formula groups.	after 2 weeks on each of 2 diets (cross-over design)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: aspiration; gastrostomy; bile acid; blenderized
• Other Study ID Numbers: IRB-P00049734 Aim 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No