Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amino acid-based formula (e.g., elecare, neocate) | Active Comparator |
| |
| low bile acid binding blenderized diet (e.g., real food blends) | Active Comparator |
| |
| high bile acid binding blenderized diet (proprietary) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amino acid based formula (e.g. Elecare Jr) | Drug | We will administer one bolus of an amino acid based formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric bile acid concentration | Mean difference in gastric bile acid concentrations between start of feed and four hours following feed | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric bile acid concentration | Differences in gastric bile acid concentrations from start of feed to 1, 2 and 3 hours after feed between groups | 1, 2 and 3 hours |
| Correlations between gastric bile acid and gastroesophageal reflux Likert scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Rosen | Contact | 617-355-0897 | rachel.rosen@childrens.harvard.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| low bile acid binding blenderized diet (e.g. Kate Farms) | Drug | We will administer one bolus of a low bile acid binding blenderized diet |
|
| high bile acid binding blenderized diet | Drug | We will administer one bolus of a high bile acid binding blenderized diet |
|
Correlations between the postprandial changes in gastric bile acid concentrations and gastroesophageal reflux Likert scores
| Baseline to 1, 2, 3 and 4 hours post-prandial |
| Correlation of symptom scores with gastric and salivary bile acid concentration | comparison of PedsGIQL scores, GERD Likert scores, and PC-QoL scores with baseline gastric and salivary bile acid concentrations | baseline |
| Correlation of gastric and salivary bile acid concentrations | correlations between gastric and salivary bile acid concentrations at each time point | 0, 1, 2, 3 and 4 hours post-prandial |
| correlations between C13 excretion rates and gastric and salivary bile acid concentrations | correlations between C13 excretion rates and gastric and salivary bile acid concentrations | Baseline to 1, 2, 3 and 4 hours post-prandial |