Actively Recruiting
The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations A Novel Intervention for Children at Risk for Aspiration-Associated Complications
Led by Boston Children's Hospital · Updated on 2025-12-26
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children and young adults aged 5 to 21 years who have feeding difficulties, aspiration risks, and use gastrostomy tubes for nutrition. The study aims to compare how three different diets affect bile acid levels in the stomach and saliva after eating. This includes an amino acid-based formula and two types of blenderized diets with different bile acid-binding properties. The goal is to better understand how these diets may influence upper gastrointestinal bile acid concentrations and related symptoms. Participants who normally receive an amino acid-based formula will be given the same during the study, while those who receive blenderized feeds will be randomly assigned to either a high or low bile acid-binding blenderized diet. Each participant will receive one bolus feed through their gastrostomy tube. The study involves an acute physiology design focusing on a 4-hour timeframe after feeding to measure bile acid concentrations. During the study, researchers will measure gastric bile acid levels at several time points from baseline up to 4 hours after feeding, along with saliva bile acid levels and symptom scores related to reflux. They will also analyze correlations between bile acid levels and other clinical markers. Participants must stop certain medications 72 hours before the study and will be observed carefully during the 4-hour post-feeding period. This study is sponsored by Boston Children's Hospital and runs until August 2030.
CONDITIONS
Brief 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 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
- Aged between 5 and 21 years
You will not qualify if you...
- Have received a fundoplication surgery
- Receive post-pyloric feeds
- Require medication or flush administration during the four-hour study period
- Are allergic to any component of the study diets
- Taking acid suppression or motility medications that cannot be stopped at least 72 hours prior to participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single dosing with assessments up to 4 hours post-prandial
Participants receive one bolus of an amino acid based formula, a low bile acid binding blenderized diet, or a high bile acid binding blenderized diet to reduce upper gastrointestinal bile acid concentrations.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
R
Rachel Rosen
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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