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

N/ANot Yet RecruitingNCT06913621

Boston Children's Hospital138 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

138

Conditions

Feeding Difficulties Gastrostomy Aspiration

Interventions

amino acid formulaDRUG

amino acid formula for 6 months

low bile acid binding blenderized dietDRUG

low bile acid binding blenderized diet for 6 months

high bile acid binding blenderized dietDRUG

high bile acid binding blenderized diet for 6 months

Eligibility

Sex: ALLMin age: 5 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

total hospitalization and emergency room visits rates

total hospitalization and emergency room visits rates between participants receiving H-BBB and those receiving L-BBB or an amino acid-based formula

Time frame: 6 months

Secondary Outcomes

differences in pulmonary, gastrointestinal or ICU admission rates

differences in pulmonary, gastrointestinal or ICU admission rates between diets

Time frame: 6 months

differences in bile acid concentrations

differences in bile acid concentrations between diets

Time frame: 6 months

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

Time frame: 6 months

differences in metagenomic patterns between diets

Time frame: 6 months

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

Time frame: 6 months

Data from ClinicalTrials.gov

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