Trials / Not Yet Recruiting
Not Yet RecruitingNCT06913621
The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
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 3)
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 138 (estimated)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 5 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | amino acid formula | amino acid formula for 6 months |
| DRUG | low bile acid binding blenderized diet | low bile acid binding blenderized diet for 6 months |
| DRUG | high bile acid binding blenderized diet | high bile acid binding blenderized diet for 6 months |
Timeline
- Start date
- 2026-07-01
- Primary completion
- 2030-08-01
- Completion
- 2030-08-01
- First posted
- 2025-04-06
- Last updated
- 2025-12-30
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06913621. Inclusion in this directory is not an endorsement.