The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5-21
SponsorBoston Children's Hospital
About this trial
We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe.
Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.
Eligibility criteria
Qualifiers
receive at least 80% of their nutritional needs by gastrostomy
receive either an amino acid-based formula, an International Dysphagia Diet Standardization Initiative level 4 commercial blend, or a home blend
can receive bolus feeds of 240 cc within 30 minutes or less
Disqualifiers
have received a fundoplication
receive post-pyloric feeds
require medication/flush administration during the four-hour study period
are allergic to any component of the study diets.
Trial design
Treatments tested in this trial
- amino acid based formula (e.g. Elecare Jr)
- low bile acid binding blenderized diet (e.g. Kate Farms)
- high bile acid binding blenderized diet
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov