Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07303738
PHASE4

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

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

5 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12-01

Completion Date

2030-08

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

DRUG

amino acid based formula (e.g. Elecare Jr)

We will administer one bolus of an amino acid based formula

DRUG

low bile acid binding blenderized diet (e.g. Kate Farms)

We will administer one bolus of a low bile acid binding blenderized diet

DRUG

high bile acid binding blenderized diet

We will administer one bolus of a high bile acid binding blenderized diet

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States