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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low bile binding then high bile binding blenderized diets | Experimental | 2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets |
|
| High bile binding then low bile binding blenderized diets | Experimental | 2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets |
|
| amino acid-based formula | No Intervention | Observational arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low bile acid binding blenderized diet | Drug | Low bile acid binding blenderized diet administered for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric bile acid concentration | differences in total gastric bile acid concentrations at the end of each diet period | after 2 weeks on each of 2 diets (cross-over design) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric bile acid concentration | changes in gastric bile acid composition (e.g., change in the proportion of gastric conjugated:unconjugated bile acid) between diet periods | after 2 weeks on each of 2 diets (cross-over design) |
| Symptom scores |
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Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria
Pediatric patients ages 5 to 21 in the observational arm Inclusion
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| High bile acid binding blenderized diet | Drug | High bile acid binding blenderized diet administered for 2 weeks |
|
changes in symptoms over the two weeks between diet periods
| after 2 weeks on each of 2 diets (cross-over design) |
| Salivary and stool bile acid concentrations | changes in the total salivary and stool BA concentrations between diet periods; | after 2 weeks on each of 2 diets (cross-over design) |
| Serum complement 4 (C4) | changes in serum C4 between diet periods | after 2 weeks on each of 2 diets (cross-over design) |
| gastric, salivary, and stool bile acid | 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. | after 2 weeks on each of 2 diets (cross-over design) |