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

Boston Children's Hospital

Status: Begins enrollment in 4 months

Conditions: Aspiration; Gastrostomy; Feeding Difficulties

Treatments: Drug: high bile acid binding blenderized diet; Drug: low bile acid binding blenderized diet; Drug: amino acid formula

Study type: Observational

Funder types: Other

Identifiers

NCT06913621

IRB-P00049734 Aim 3

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

138 participants in 3 patient groups

amino acid-based formula

Treatment:

Drug: amino acid formula

Low bile binding blenderized diet

Treatment:

Drug: low bile acid binding blenderized diet

High bile binding blenderized diet

Treatment:

Drug: high bile acid binding blenderized diet