Recruiting

Amino Acid & Blenderized

Sponsor:

Boston Children's Hospital

Code:

NCT07303738

Conditions

Feeding Difficulties

Aspiration

Gastrostomy

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

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

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

high bile acid binding blenderized diet

Study Details

Brief summary:

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.

Conditions

Feeding Difficulties

Aspiration

Gastrostomy

Study ID

NCT07303738

Start date

Dec 1, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

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

experimental: high bile acid binding blenderized diet (proprietary)

Interventions

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

We will administer one bolus of an amino acid based formula

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

We will administer one bolus of a low bile acid binding blenderized diet

high bile acid binding blenderized diet

We will administer one bolus of a high bile acid binding blenderized diet

Primary outcome measure

  • Gastric bile acid concentration [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Rachel Rosen

617-355-0897rachel.rosen@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • blenderized
  • bile acid
  • gastrostomy
  • aspiration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-08-03.