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

NCT ID: NCT06913621

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-07-31

Study Completion Date

2030-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Feeding Difficulties Gastrostomy Aspiration

Keywords

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blenderized bile acid gastrostomy aspiration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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amino acid-based formula

amino acid formula

Intervention Type DRUG

amino acid formula for 6 months

Low bile binding blenderized diet

low bile acid binding blenderized diet

Intervention Type DRUG

low bile acid binding blenderized diet for 6 months

High bile binding blenderized diet

high bile acid binding blenderized diet

Intervention Type DRUG

high bile acid binding blenderized diet for 6 months

Interventions

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amino acid formula

amino acid formula for 6 months

Intervention Type DRUG

low bile acid binding blenderized diet

low bile acid binding blenderized diet for 6 months

Intervention Type DRUG

high bile acid binding blenderized diet

high bile acid binding blenderized diet for 6 months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rachel Rosen

Director, Aerodigestive Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRB-P00049734 Aim 3

Identifier Type: -

Identifier Source: org_study_id