The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)

ConditionsFeeding Difficulties Gastrostomy Aspiration

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Low bile acid binding blenderized diet
Drug
Low bile acid binding blenderized diet administered for 2 weeks
High bile acid binding blenderized diet
Drug
High bile acid binding blenderized diet administered for 2 weeks

Treatment groups

66 Participants

are divided into 3 treatment groups

Group A: Low bile binding then high bile binding blenderized dietsExperimental treatment 2 interventions

Group B: High bile binding then low bile binding blenderized dietsExperimental treatment 2 interventions

Group C: amino acid-based formulaNo intervention 0 interventions

Trial outcomes