Aspiration, Feeding Difficulties, Gastrostomy
Conditions
Keywords
blenderized, bile acid, gastrostomy, aspiration
Brief summary
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.
Interventions
DRUGamino acid based formula (e.g. Elecare Jr)
We will administer one bolus of an amino acid based formula
DRUGlow bile acid binding blenderized diet (e.g. Kate Farms)
We will administer one bolus of a low bile acid binding blenderized diet
We will administer one bolus of a high bile acid binding blenderized diet
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. To participate in this study, if patients are taking acid suppression or motility medications (e.g., erythromycin, azithromycin, prucalopride), they will need to stop these at least 72 hours prior to participation in this aim.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric bile acid concentration | 4 hours | Mean difference in gastric bile acid concentrations between start of feed and four hours following feed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric bile acid concentration | 1, 2 and 3 hours | Differences in gastric bile acid concentrations from start of feed to 1, 2 and 3 hours after feed between groups |
| Correlations between gastric bile acid and gastroesophageal reflux Likert scale | Baseline to 1, 2, 3 and 4 hours post-prandial | Correlations between the postprandial changes in gastric bile acid concentrations and gastroesophageal reflux Likert scores |
| Correlation of symptom scores with gastric and salivary bile acid concentration | baseline | comparison of PedsGIQL scores, GERD Likert scores, and PC-QoL scores with baseline gastric and salivary bile acid concentrations |
| Correlation of gastric and salivary bile acid concentrations | 0, 1, 2, 3 and 4 hours post-prandial | correlations between gastric and salivary bile acid concentrations at each time point |
| correlations between C13 excretion rates and gastric and salivary bile acid concentrations | Baseline to 1, 2, 3 and 4 hours post-prandial | correlations between C13 excretion rates and gastric and salivary bile acid concentrations |
Countries
United States
Contacts
CONTACTRachel Rosen
Outcome results
None listed