The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5-21
SponsorBoston Children's Hospital
About this trial
Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.
Eligibility criteria
Qualifiers
receive blenderized feeds or will start receiving blenderized feeds
have no known allergies to ingredients in blenderized feeds;
receive their bolus feeds within 30 minutes or less
can receive their feeds by syringe push
Disqualifiers
have undergone anti-reflux surgery
receive post-pyloric feeds
are allergic to any component of the administered diets
cannot receive their gastrostomy feeds over 30 minutes
Trial design
Treatments tested in this trial
- Low bile acid binding blenderized diet
- High bile acid binding blenderized diet
Treatment groups
66 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov