The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)
NCT ID: NCT07303868
Last Updated: 2025-12-26
Study Results
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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NOT_YET_RECRUITING
PHASE4
66 participants
INTERVENTIONAL
2026-07-31
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Low bile binding then high bile binding blenderized diets
2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets
Low bile acid binding blenderized diet
Low bile acid binding blenderized diet administered for 2 weeks
High bile acid binding blenderized diet
High bile acid binding blenderized diet administered for 2 weeks
High bile binding then low bile binding blenderized diets
2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets
Low bile acid binding blenderized diet
Low bile acid binding blenderized diet administered for 2 weeks
High bile acid binding blenderized diet
High bile acid binding blenderized diet administered for 2 weeks
amino acid-based formula
Observational arm
No interventions assigned to this group
Interventions
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Low bile acid binding blenderized diet
Low bile acid binding blenderized diet administered for 2 weeks
High bile acid binding blenderized diet
High bile acid binding blenderized diet administered for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
Pediatric patients ages 5 to 21 in the observational arm Inclusion
* receive at least 80% of their nutritional needs via gastrostomy
* are taking an amino acid formula
* have not undergone antireflux surgery Exclusion
* have undergone anti-reflux surgery
* receive post-pyloric feeds
* are not receiving an amino acid-based formula.
5 Years
21 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Rachel Rosen
Director, Aerodigestive Center
Other Identifiers
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IRB-P00049734 Aim 2
Identifier Type: -
Identifier Source: org_study_id