Status:
NOT_YET_RECRUITING
The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
Lead Sponsor:
Boston Children's Hospital
Conditions:
Feeding Difficulties
Gastrostomy
Eligibility:
All Genders
5-21 years
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 ...
Eligibility Criteria
Inclusion
- 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
- have undergone anti-reflux surger
- receive post-pyloric feeds
- receive regular daily prophylactic antibiotics.
Key Trial Info
Start Date :
July 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06913621
Start Date
July 1 2026
End Date
August 1 2030
Last Update
December 30 2025
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