The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: amino acid formula, low bile acid binding blenderized diet, high bile acid binding blenderized diet.
- Who it may be relevant to
- Registry conditions: Feeding Difficulties, Gastrostomy, Aspiration. Basic parameters: 5 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
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.
Interventions
- Drug amino acid formula
amino acid formula for 6 months - Drug low bile acid binding blenderized diet
low bile acid binding blenderized diet for 6 months - Drug high bile acid binding blenderized diet
high bile acid binding blenderized diet for 6 months
Primary outcome measures
- total hospitalization and emergency room visits rates [Time frame: 6 months]
Secondary outcome measures (5)
- differences in pulmonary, gastrointestinal or ICU admission rates [Time frame: 6 months]
- differences in bile acid concentrations [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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06913621 · IRB-P00049734 Aim 3