Eosinophilic EsophagitisNCT03615950
Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Eosinophilic esophagitis (EoE) is characterized by allergy-driven inflammation of the esophagus leading to a variety of gastrointestinal symptoms and increased healthcare utilization. While considered a rare disease, EoE is rapidly increasing in prevalence in the United States. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Bone Mineral Density (DEXA) scan, Vitamin D Measurement and Height measurement
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2018to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Child
Study population: 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.
Who may be able to join
- Intervention:
- Age 5-12 years
- 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
- 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:
- Age 5-12 years
- Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE
- Not treated with swallowed corticosteroids
Who cannot join
- Intervention and controls:
- Non-English speaking
- Patients actively taking systemic corticosteroids or previous use of systemic corticosteroids within the past 6 months
- Patients actively taking inhaled corticosteroids or prior use of inhaled corticosteroids in the 6 months prior to screening
- Current or previous treatment with swallowed corticosteroids for EoE at the time of screening
- Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE) is characterized by allergy-driven inflammation of the esophagus leading to a variety of gastrointestinal symptoms and increased healthcare utilization. While considered a rare disease, EoE is rapidly increasing in prevalence in the United States. Treatment options are limited and include dietary modifications with the elimination of suspected food triggers or pharmacological options including proton pump inhibitors (PPIs) and swallowed corticosteroids. Compliance to strict elimination diets is difficult thus many patients elect to use swallowed corticosteroids. Because nearly half of all EoE patients are treated with swallowed corticosteroids there is a growing concern regarding the long-term effects of this class of medication.4
It is known that oral corticosteroids can compromise bone mineral density and growth velocity5-7. Furthermore, there have been multiple studies exploring the relationship between inhaled corticosteroids (ICS) and endocrine effects in asthmatics. While the risk of ICS use is less compared to systemic corticosteroids, higher ICS doses do cause deleterious effects on growth and bone health8-11. Currently, there are no published studies examining the effect of swallowed corticosteroids on bone mineral density or growth velocity in patients with EoE. Given the route of administration, there may be more systemic absorption leading to a higher risk of long-term complications.
Read more
The proposed work will address the following specific aims:
Specific Aim 1: Assess effects of swallowed corticosteroids on bone mineral density (primary outcome) in children 5-12 years of age with EoE compared to age matched controls.
Specific Aim 2: Evaluation of the effect of swallowed corticosteroids on growth velocity.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Bone Mineral Density (DEXA) scan, Vitamin D Measurement, Height measurement, Assessment of medication compliance
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Mineral Density (DEXA) scanDiagnostic test
Radiologic assessment of bone mineral density in the lumbar spine. This will be performed at screening. If abnormal at screening, subjects will not be enrolled. For enrolled subjects, DEXA will be repeated at 12 months.
Vitamin D MeasurementDiagnostic test
Measurement of 25-hydroxy vitamin D levels through the blood at baseline and 12 months. If low for age, subjects will receive dietary counseling to increase intake to recommended levels. Primary care providers of enrolled subjects will be notified of abnormal results.
Height measurementDiagnostic test
Height will be measured at baseline and 12 months.
Assessment of medication complianceOther
Subjects enrolled in the intervention group will undergo assessment of compliance with swallowed corticosteroids prescribed by their clinical provider. This will be performed at 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | 30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider. Receives: Diagnostic Test: Bone Mineral Density (DEXA) scan; Diagnostic Test: Vitamin D Measurement; Diagnostic Test: Height measurement; Other: Assessment of medication compliance | |
| Control Group | 30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group. Receives: Diagnostic Test: Bone Mineral Density (DEXA) scan; Diagnostic Test: Vitamin D Measurement; Diagnostic Test: Height measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of swallowed corticosteroids on bone mineral density
Change in bone mineral density over 1 year while being treated with swallowed corticosteroids compared to age-matched controls
Measured: 12 months
Secondary outcomes (1)
Effects of swallowed corticosteroids on linear growth
Changes in linear growth over 1 year while being treated with swallowed corticosteroids compared to controls
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study startFeb 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615950
- Sponsor's protocol ID
- ACHEOEBMD
- Status last verified
- Sep 2025
- First submitted
- 24 Jul 2018
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT03615950
- Acronym / sponsor ID
- ACHEOEBMD
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eosinophilic esophagitis (EoE) is characterized by allergy-driven inflammation of the esophagus leading to a variety of gastrointestinal symptoms and increased healthcare utilization. While considered a rare disease, EoE is rapidly increasing in prevalence in the United States. Treatment options are limited and include dietary modifications with the elimination of suspected food triggers or pharmacological options including proton pump inhibitors (PPIs) and swallowed corticosteroids. Compliance to strict elimination diets is difficult thus many patients elect to use swallowed corticosteroids. Because nearly half of all EoE patients are treated with swallowed corticosteroids there is a growing concern regarding the long-term effects of this class of medication.4
It is known that oral corticosteroids can compromise bone mineral density and growth velocity5-7. Furthermore, there have been multiple studies exploring the relationship between inhaled corticosteroids (ICS) and endocrine effects in asthmatics. While the risk of ICS use is less compared to systemic corticosteroids, higher ICS doses do cause deleterious effects on growth and bone health8-11. Currently, there are no published studies examining the effect of swallowed corticosteroids on bone mineral density or growth velocity in patients with EoE. Given the route of administration, there may be more systemic absorption leading to a higher risk of long-term complications.
The proposed work will address the following specific aims:
Specific Aim 1: Assess effects of swallowed corticosteroids on bone mineral density (primary outcome) in children 5-12 years of age with EoE compared to age matched controls.
Specific Aim 2: Evaluation of the effect of swallowed corticosteroids on growth velocity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Diagnostic Test: Bone Mineral Density (DEXA) scan, Diagnostic Test: Vitamin D Measurement, Diagnostic Test: Height measurement, Other: Assessment of medication compliance30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider. |
| Control Group | – | Diagnostic Test: Bone Mineral Density (DEXA) scan, Diagnostic Test: Vitamin D Measurement, Diagnostic Test: Height measurement30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (8 listed)
- Intervention:
- Controls:
Key exclusion criteria (6 listed)
- Intervention and controls:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Mineral Density (DEXA) scanRadiologic assessment of bone mineral density in the lumbar spine. This will be performed at screening. If abnormal at screening, subjects will not be enrolled. For enrolled subjects, DEXA will be repeated at 12 months. | Diagnostic test | Control Group, Intervention Group |
| Vitamin D MeasurementMeasurement of 25-hydroxy vitamin D levels through the blood at baseline and 12 months. If low for age, subjects will receive dietary counseling to increase intake to recommended levels. Primary care providers of enrolled subjects will be notified of abnormal results. | Diagnostic test | Control Group, Intervention Group |
| Height measurementHeight will be measured at baseline and 12 months. | Diagnostic test | Control Group, Intervention Group |
| Assessment of medication complianceSubjects enrolled in the intervention group will undergo assessment of compliance with swallowed corticosteroids prescribed by their clinical provider. This will be performed at 6 and 12 months. | Other | Intervention Group |
Primary outcome
Effects of swallowed corticosteroids on bone mineral density
Time frame: 12 months
Change in bone mineral density over 1 year while being treated with swallowed corticosteroids compared to age-matched controls
1 secondary outcome
Effects of swallowed corticosteroids on linear growth
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of swallowed corticosteroids on bone mineral density (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.