Aspiration, Feeding Difficulties, Gastrostomy
Conditions
Keywords
blenderized, bile acid, gastrostomy, aspiration
Brief summary
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.
Interventions
Low bile acid binding blenderized diet administered for 2 weeks
High bile acid binding blenderized diet administered for 2 weeks
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria * receive at least 80% of their nutritional needs via gastrostomy * 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
Exclusion criteria
* 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 * require a feeding pump for feed administration (as the H-BBB is too thick for pump administration). Pediatric patients ages 5 to 21 in the observational arm Inclusion * receive at least 80% of their nutritional needs via gastrostomy * are taking an amino acid formula * have not undergone antireflux surgery Exclusion * have undergone anti-reflux surgery * receive post-pyloric feeds * are not receiving an amino acid-based formula.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric bile acid concentration | after 2 weeks on each of 2 diets (cross-over design) | differences in total gastric bile acid concentrations at the end of each diet period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric bile acid concentration | after 2 weeks on each of 2 diets (cross-over design) | changes in gastric bile acid composition (e.g., change in the proportion of gastric conjugated:unconjugated bile acid) between diet periods |
| Symptom scores | after 2 weeks on each of 2 diets (cross-over design) | changes in symptoms over the two weeks between diet periods |
| Salivary and stool bile acid concentrations | after 2 weeks on each of 2 diets (cross-over design) | changes in the total salivary and stool BA concentrations between diet periods; |
| Serum complement 4 (C4) | after 2 weeks on each of 2 diets (cross-over design) | changes in serum C4 between diet periods |
| gastric, salivary, and stool bile acid | after 2 weeks on each of 2 diets (cross-over design) | changes in gastric, salivary, and stool bile acid over time between the high bile binding blend, low bile binding blend and amino acid-based formula groups. |
Outcome results
None listed