Study on High Bile-binding Foods for Feeding Difficulties

This study is looking at how different diets affect bile acid levels in the stomach and saliva of young people (ages 5-21) who get most of their nutrition through a gastrostomy (feeding tube). We are comparing three diets: an amino acid-based formula (like Elecare Jr), a low bile acid-binding blenderized diet (like Kate Farms), and a high bile acid-binding blenderized diet. The goal is to see if these diets change the amount of bile acid in your stomach after 4 hours. You can join if you receive at least 80% of your nutrition by gastrostomy and can receive bolus feeds of 240 cc within 30 minutes. The study status is currently unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. Participants who regularly receive blenderized feeds will be randomly assigned to either the high or low bile acid binding blenderized feed.
What's involved
You will receive one bolus of a specific diet through your gastrostomy tube. Researchers will then measure bile acid concentrations in your stomach and saliva over a 4-hour period.
Compensation
Not stated in the trial record.
Follow-up
Bile acid concentrations will be measured for 4 hours after the diet is given.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07303738

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

Recruiting
PHASE4Ages 5–21Interventional
Boston Children's Hospital
~60 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:amino acid based formula (e.g. Elecare Jr)low bile acid binding blenderized diet (e.g. Kate Farms)high bile acid binding blenderized diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gastric bile acid concentration
Measured over 4 hours
Feeding Difficulties
Aspiration
Gastrostomy

NCT07303738

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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.
  • Gastric bile acid concentration4 hours

    Mean difference in gastric bile acid concentrations between start of feed and four hours following feed