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Cancelled study: do swallowed steroids affect Kids' bones?

NCT ID NCT03615950

Knowledge-focused Sponsor: Arkansas Children's Hospital Research Institute 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study was designed to check if swallowed corticosteroids, used to treat eosinophilic esophagitis (EoE) in children aged 5-12, affect bone density and growth over one year. It planned to compare these children to healthy age-matched controls. However, the study was withdrawn before any participants were enrolled, so no results are available.

What this could mean

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

Active substance
swallowed corticosteroids (budesonide or fluticasone)

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.

Expected to start

Feb 2018

An estimate. Start dates often move.

Expected to finish

Jul 2020

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

We will recruit 30 children, ages 5-12 years, with eosinophilic esophagitis (EoE) and 30 age and sex-matched controls from the Arkansas Children's Hospital allergy clinic to participate in this prospective study. Controls will be age- and gender-matched in a 1:1 ratio with EoE subjects but will not be required to have a diagnosis of EoE. Control subjects will not be treated with swallowed corticosteroids.

Ages

5 to 12 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: * Intervention: 1. Age 5-12 years 2. Diagnosis of EoE based upon a peak eosinophil count of ≥ 15 eosinophils/high powered field (hpf) on at least one esophageal biopsy while on a minimum of 8 weeks of PPI therapy 3. Patient/Family has elected to start swallowed corticosteroids for the treatment of EoE with a minimum daily dose of at least 0.5 mg budesonide or 440 mcg fluticasone. The decision to start swallowed corticosteroids will be made based upon the judgement of the provider, potential subject, and family during a clinic visit and will not be part of the research procedures. * Controls: 1. Age 5-12 years 2. Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE 3. Not treated with swallowed corticosteroids Exclusion Criteria: * Intervention and controls: 1. Non-English speaking 2. Patients actively taking systemic corticosteroids or previous use of systemic corticosteroids within the past 6 months 3. Patients actively taking inhaled corticosteroids or prior use of inhaled corticosteroids in the 6 months prior to screening 4. Current or previous treatment with swallowed corticosteroids for EoE at the time of screening 5. Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis

As listed by the trial registrant

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

Eosinophilic esophagitis

Contacts and locations

Locations

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

More trials for these conditions

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