The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)

Boston Children's Hospital

Status and phase: Enrolling; Phase 4

Conditions: Gastrostomy; Aspiration; Feeding Difficulties

Treatments: Drug: low bile acid binding blenderized diet (e.g. Kate Farms); Drug: amino acid based formula (e.g. Elecare Jr); Drug: high bile acid binding blenderized diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07303738

IRB-P00049734 Aim 1

Details and patient eligibility

About

We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe.

Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• receive at least 80% of their nutritional needs by gastrostomy
• receive either an amino acid-based formula, an International Dysphagia Diet Standardization Initiative level 4 commercial blend, or a home blend
• can receive bolus feeds of 240 cc within 30 minutes or less

Exclusion criteria

• have received a fundoplication
• receive post-pyloric feeds
• require medication/flush administration during the four-hour study period
• are allergic to any component of the study diets.

To participate in this study, if patients are taking acid suppression or motility medications (e.g., erythromycin, azithromycin, prucalopride), they will need to stop these at least 72 hours prior to participation in this aim.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

amino acid-based formula (e.g., elecare, neocate)

Active Comparator group

Treatment:

Drug: amino acid based formula (e.g. Elecare Jr)

low bile acid binding blenderized diet (e.g., real food blends)

Active Comparator group

Treatment:

Drug: low bile acid binding blenderized diet (e.g. Kate Farms)

high bile acid binding blenderized diet (proprietary)

Experimental group

Treatment:

Drug: high bile acid binding blenderized diet