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Appetite pill may help Tube-Fed kids switch to eating

NCT ID NCT03815019

Symptom relief Sponsor: University of Kansas Medical Center 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a drug called megestrol (an appetite stimulant) could help children aged 9 months to 9 years who rely on feeding tubes transition to eating by mouth. About 70 kids received either megestrol or a placebo, along with a 24-week behavioral feeding program. The main goal was to see if more children could get at least 90% of their calories from oral feeding.

What this could mean

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

Active substance
megestrol acetate (appetite stimulant)
What this could lead to
If it works, this could offer a safe, short-term medication to help children with feeding tubes learn to eat by mouth, reducing dependence on tube feeding.
What could go wrong
This is a small, completed phase 4 trial with only 70 participants, so results may not apply to all children. Megestrol can cause side effects like adrenal insufficiency, and the benefit may be modest.

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

70 people

The number who actually took part.

Started

Aug 2019

Finished

Mar 2025

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

9 to 108 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Males and females aged 9 months to 9y0m at the time of consent. 2. Able to obtain parental or legal guardian written informed consent from subjects as applicable by local laws and regulations. 3. Subjects must have a G or G/J tube. 4. Subjects must receive over 80% of their total daily calorie needs from a tube in order to be classified as tube dependent. 5. Subjects must have a ≥ 3 month history of feeding problems as identified by a diagnosis from a multidisciplinary feeding team, and must have permission from the physician on the team to ensure that they are medically stable enough to participate in a weaning study. 6. Subjects must possess the oral motor skills necessary for eating. Subjects must possess behavioral skills necessary for mealtimes. Exclusion Criteria: 1. Children receiving oral or inhaled steroids. 2. Parent has a known developmental delay or cognitive impairment that may make participation in the study difficult (children with these issues will not be excluded). 3. Children receiving intensive (defined as more than one session per month) behavioral feeding therapy with a licensed psychologist (previous behavioral feeding therapy is not an exclusion criterion; neither is current oral-motor, sensory, or speech therapy). 4. Children of non-English speaking parents.

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Conditions

The condition(s) this trial relates to.

avoidant/restrictive food intake disorder Feeding Behavior

As listed by the trial registrant

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

Feeding behavior Feeding disorder of infancy or early childhood

Contacts and locations

Locations

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232, United States

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

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