Actively Recruiting
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
Led by Boston Children's Hospital · Updated on 2025-12-26
60
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receive at least 80% of nutritional needs by gastrostomy
- Use either an amino acid-based formula, an IDDSI level 4 commercial blend, or a home blenderized feed
- Able to receive bolus feeds of 240 cc within 30 minutes or less
You will not qualify if you...
- Have received a fundoplication surgery
- Currently receive post-pyloric feeds
- Require medication or flush administration during the four-hour study period
- Are allergic to any component of the study diets
- Cannot stop acid suppression or motility medications at least 72 hours before participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
R
Rachel Rosen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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