Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06913621

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Feeding Difficulties Aspiration Gastrostomy

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

amino acid formula

Drug

amino acid formula for 6 months

Low bile acid binding blenderized diet

Drug

low bile acid binding blenderized diet for 6 months

high bile acid binding blenderized diet

Drug

high bile acid binding blenderized diet for 6 months

Primary outcomes

  1. total hospitalization and emergency room visits rates

    Time frame: 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 outcomes

  1. differences in pulmonary, gastrointestinal or ICU admission rates

    Time frame: 6 months

    differences in pulmonary, gastrointestinal or ICU admission rates between diets

  2. differences in bile acid concentrations

    Time frame: 6 months

    differences in bile acid concentrations between diets

  3. correlations between microbial abundance and diversity and hospitalization and emergency room visit rates

    Time frame: 6 months

    correlations between microbial abundance and diversity and hospitalization and emergency room visit rates

  4. differences in metagenomic patterns between diets

    Time frame: 6 months

  5. correlations between admission rates by diet type and short chain fatty acid concentrations

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 6, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.