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NOT YET RECRUITING
NCT07303868
PHASE4

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

Summary

Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.

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 2)

Key Details

Gender

All

Age Range

5 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-07

Completion Date

2030-08

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

DRUG

Low bile acid binding blenderized diet

Low bile acid binding blenderized diet administered for 2 weeks

DRUG

High bile acid binding blenderized diet

High bile acid binding blenderized diet administered for 2 weeks