The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-21
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
have undergone anti-reflux surger
receive post-pyloric feeds
receive regular daily prophylactic antibiotics.
Trial design
Treatments tested in this trial
- amino acid formula
- low bile acid binding blenderized diet
- high bile acid binding blenderized diet
Treatment groups
138 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov