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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07303738
Phase
PHASE4
Status
Recruiting
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Conditions

  • Aspiration
  • Feeding Difficulties
  • Gastrostomy

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • amino acid based formula (e.g. Elecare Jr) — DRUG
    We will administer one bolus of an amino acid based formula
  • low bile acid binding blenderized diet (e.g. Kate Farms) — DRUG
    We will administer one bolus of a low bile acid binding blenderized diet
  • high bile acid binding blenderized diet — DRUG
    We will administer one bolus of a high bile acid binding blenderized diet

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Mar 2025
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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)

Primary Outcome Measure

Gastric bile acid concentration [ Time Frame: 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-

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By research site
Boston Children's Hospital· Boston, MA

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