Home › NCT07303738

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)

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 (Aim 1)

Who can join

Ages 5 to 21 · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

About the 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.

What is being tested

• amino acid based formula (e.g. Elecare Jr) (drug)
• low bile acid binding blenderized diet (e.g. Kate Farms) (drug)
• high bile acid binding blenderized diet (drug)

Sponsor: Boston Children's Hospital · Participants: 60 · Started: Dec 1, 2025

Contact the study team

• Rachel Rosen · Phone: 617-355-0897

Official record on ClinicalTrials.gov — NCT07303738

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.