Not Yet RecruitingNot Applicable

The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)

138 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range5 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * receive at least 80% of their nutritional needs via gastrostomy * receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula * receive their bolus feeds within 30 minutes or less. Exclusion Criteria: * have undergone anti-reflux surger * receive post-pyloric feeds * receive regular daily prophylactic antibiotics.

What they're measuring

total hospitalization and emergency room visits rates

Timeframe: 6 months

Trial details

NCT IDNCT06913621

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-08

View on ClinicalTrials.gov More Feeding Difficulties trials