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Could a common allergy drug help picky eaters gain weight?

NCT ID NCT06751290

Symptom relief Sponsor: University of Miami 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether cyproheptadine, a drug that boosts appetite, can improve eating habits in children aged 2 to 6 with pediatric feeding disorders. Researchers gave the drug along with nutritional and behavioral counseling to 18 children. The goal was to see if kids would eat more foods, show less fear of new foods, and gain weight.

What this could mean

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

Active substance
Cyproheptadine (appetite stimulant)
What this could lead to
If it works, this could offer a simple medication option to help young children with feeding disorders eat more and gain weight.
What could go wrong
This is a small, completed Phase 4 trial with only 18 participants, so results may not apply to all children. The drug may cause side effects or not improve eating habits significantly.

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

18 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2026

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

2 to 6 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.

Inclusion Criteria: * Any patient aged 2-6 years of age who presents to Pediatric Gastroenterology Clinic with complaint of "poor weight gain, malnutrition, failure to thrive/weight faltering, picky eating, or feeding issues" who screens positive for a pediatric feeding disorder using the Child eating disorder questionnaire (CEBQ) * Age Range: 2-6 years * English or Spanish speaking Exclusion Criteria: * Patients who are tube fed * Patients who are overweight (BMI at 85th%tile or greater) * Patients who have active symptoms from a diagnosis of a GI disorder (Inflammatory Bowel Disease, Eosinophilic Esophagitis, Gastritis) * Patients actively undergoing behavioral feeding therapy

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Conditions

The condition(s) this trial relates to.

avoidant/restrictive food intake disorder Bronchiolitis Obliterans Syndrome Malnutrition

As listed by the trial registrant

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

Avoidant restrictive food intake disorder Pediatric feeding disorder, chronic

Contacts and locations

Locations

  • University of Miami Department of Pediatric Gastroenterology

    Miami, Florida, 30345, United States

More trials for these conditions

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