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

December 23, 2025 updated by: Rachel Rosen, Boston Children's Hospital

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children requiring gastrostomy tube feeds for feeding difficulties

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
amino acid-based formula
Drug: amino acid formula
amino acid formula for 6 months
Low bile binding blenderized diet
Drug: low bile acid binding blenderized diet
low bile acid binding blenderized diet for 6 months
High bile binding blenderized diet
Drug: high bile acid binding blenderized diet
high bile acid binding blenderized diet for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences in pulmonary, gastrointestinal or ICU admission rates
Time Frame: 6 months
differences in pulmonary, gastrointestinal or ICU admission rates between diets
6 months
differences in bile acid concentrations
Time Frame: 6 months
differences in bile acid concentrations between diets
6 months
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
6 months
differences in metagenomic patterns between diets
Time Frame: 6 months
6 months
correlations between admission rates by diet type and short chain fatty acid concentrations
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

March 29, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00049734 Aim 3

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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