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

Boston Children's Hospital

Status and phase: Begins enrollment in 4 months; Phase 4

Conditions: Aspiration; Gastrostomy; Feeding Difficulties

Treatments: Drug: Low bile acid binding blenderized diet; Drug: High bile acid binding blenderized diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07303868

IRB-P00049734 Aim 2

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria

• receive at least 80% of their nutritional needs via gastrostomy
• receive blenderized feeds or will start receiving blenderized feeds
• have no known allergies to ingredients in blenderized feeds;
• receive their bolus feeds within 30 minutes or less
• can receive their feeds by syringe push Exclusion criteria
• have undergone anti-reflux surgery
• receive post-pyloric feeds
• are allergic to any component of the administered diets
• cannot receive their gastrostomy feeds over 30 minutes
• require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).

Pediatric patients ages 5 to 21 in the observational arm Inclusion

• receive at least 80% of their nutritional needs via gastrostomy
• are taking an amino acid formula
• have not undergone antireflux surgery Exclusion
• have undergone anti-reflux surgery
• receive post-pyloric feeds
• are not receiving an amino acid-based formula.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Low bile binding then high bile binding blenderized diets

Experimental group

Description:

2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets

Treatment:

Drug: High bile acid binding blenderized diet

Drug: Low bile acid binding blenderized diet

High bile binding then low bile binding blenderized diets

Experimental group

Description:

2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets

Treatment:

Drug: High bile acid binding blenderized diet

Drug: Low bile acid binding blenderized diet

amino acid-based formula

No Intervention group

Description:

Observational arm