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Could a botox shot in the gut ease Kids' chronic vomiting?

NCT ID NCT04250844

Symptom relief Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether injecting botulinum toxin into the pylorus—the muscle at the stomach's exit—can help children aged 30 days to 18 years who struggle with chronic nausea, vomiting, or feeding intolerance. Participants receive the injection during an upper endoscopy, and researchers track changes in quality of life and symptom severity over four weeks. The goal is to see if relaxing this muscle improves how well children tolerate feeds and reduces distressing symptoms.

What this could mean

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

Active substance
intrapyloric botulinum toxin injections
What this could lead to
If effective, this could offer a minimally invasive option to ease chronic nausea, vomiting, and feeding difficulties in children, improving their daily comfort and quality of life.
What could go wrong
This is an early-stage study, and results may not confirm benefit. Risks include procedure-related complications and the possibility that the effect is temporary or no better than a placebo.

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.

Participants

About 100 people

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

Started

Mar 2020

Expected to finish

May 2027

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.

Who is studied

Patients from our tertiary care center who are undergoing upper endoscopy with or without intrapyloric botulinum injections.

Ages

30 days to 18 years

Sex

Anyone

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.

Inclusion Criteria: * Patients with chronic nausea, vomiting, or feeding intolerance undergoing upper endoscopy with or without intrapyloric botulinum injections. * Age between 30 days and 18 years. Exclusion Criteria: * Significant uncontrolled inflammation on upper or lower endoscopy * Known inflammatory bowel disease * Uncontrolled thyroid disease * Current opioid use

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Conditions

The condition(s) this trial relates to.

eating disorder Feeding and Eating Disorders gastroparesis Vomiting

As listed by the trial registrant

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

Feeding disorders Gastroparesis Vomiting

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.