The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)

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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06913621

Enrollment

138

Registered

2025-04-06

Start date

2026-10-01

Completion date

2030-08-01

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration, Feeding Difficulties, Gastrostomy

Keywords

blenderized, bile acid, gastrostomy, aspiration

Brief summary

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.

Interventions

DRUGamino acid formula

amino acid formula for 6 months

DRUGlow bile acid binding blenderized diet

low bile acid binding blenderized diet for 6 months

DRUGhigh bile acid binding blenderized diet

high bile acid binding blenderized diet for 6 months

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 21 Years

Healthy volunteers

Inclusion criteria

* receive at least 80% of their nutritional needs via gastrostomy * receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula * receive their bolus feeds within 30 minutes or less.

Exclusion criteria

* have undergone anti-reflux surger * receive post-pyloric feeds * receive regular daily prophylactic antibiotics.

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
differences in pulmonary, gastrointestinal or ICU admission rates	6 months	differences in pulmonary, gastrointestinal or ICU admission rates between diets
differences in bile acid concentrations	6 months	differences in bile acid concentrations between diets
correlations between microbial abundance and diversity and hospitalization and emergency room visit rates	6 months	correlations between microbial abundance and diversity and hospitalization and emergency room visit rates
differences in metagenomic patterns between diets	6 months	—
correlations between admission rates by diet type and short chain fatty acid concentrations	6 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026