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

NCT07303868 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB-P00049734 Aim 2
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

blenderized; bile acid; gastrostomy; aspiration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Gastric bile acid concentration

  after 2 weeks on each of 2 diets (cross-over design)

• Symptom scores

  after 2 weeks on each of 2 diets (cross-over design)

• Salivary and stool bile acid concentrations

  after 2 weeks on each of 2 diets (cross-over design)

• Serum complement 4 (C4)

  after 2 weeks on each of 2 diets (cross-over design)

• gastric, salivary, and stool bile acid

  after 2 weeks on each of 2 diets (cross-over design)

Study Arms (3)

Low bile binding then high bile binding blenderized diets

EXPERIMENTAL

2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets

Drug: Low bile acid binding blenderized diet; Drug: High bile acid binding blenderized diet

High bile binding then low bile binding blenderized diets

EXPERIMENTAL

2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets

Drug: Low bile acid binding blenderized diet; Drug: High bile acid binding blenderized diet

amino acid-based formula

NO INTERVENTION

Observational arm

Interventions

Low bile acid binding blenderized diet DRUG

Low bile acid binding blenderized diet administered for 2 weeks

High bile binding then low bile binding blenderized diets; Low bile binding then high bile binding blenderized diets

High bile acid binding blenderized diet DRUG

High bile acid binding blenderized diet administered for 2 weeks

High bile binding then low bile binding blenderized diets; Low bile binding then high bile binding blenderized diets

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Aerodigestive Center

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: December 26, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share