The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
Eligible age
5–21 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Boston Children's Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT07303738 · last updated 2026-08-03