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No recruitment
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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | 30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider. |
| |
| Control Group | 30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Mineral Density (DEXA) scan | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of swallowed corticosteroids on linear growth | Changes in linear growth over 1 year while being treated with swallowed corticosteroids compared to controls | 12 months |
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Inclusion Criteria:
Intervention:
Controls:
Exclusion Criteria:
Intervention and controls:
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Male and Female children, 5-12 years of age are eligible. Controls are age and gender matched to those in the intervention group
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
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| Vitamin D Measurement | Diagnostic 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 measurement | Diagnostic Test | Height will be measured at baseline and 12 months. |
|
| Assessment of medication compliance | Other | 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. |
|
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015519 | Bone Density |
| D015502 | Absorptiometry, Photon |
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003947 | Diagnostic Techniques, Radioisotope |
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