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Could a special diet protect kids with feeding tubes from lung damage?

NCT ID NCT07303868

Disease control Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests whether foods that bind bile can reduce bile acid levels in the stomach and saliva of children aged 5 to 21 who rely on feeding tubes. High bile levels can lead to lung irritation if accidentally inhaled. For two weeks, participants will eat a high bile-binding diet, then switch to a low bile-binding diet, and their bile levels and symptoms will be compared. The goal is to find a simple dietary way to lower aspiration risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high bile acid-binding blenderized diet
What this could lead to
If it works, this could point toward a simple dietary change to reduce aspiration-related lung problems in children who rely on feeding tubes.
What could go wrong
This is a small, early-phase trial with only 66 participants, so results may not apply broadly. The diet change is short-term (2 weeks), and long-term benefits or risks are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aspiration Feeding difficulties Gastrostomy

How to take part

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  1. The official record

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