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This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Steroid Treatment | Pediatric patients with eosinophilic esophagitis scheduled to begin topical steroid treatment for the treatment of their condition. The type of topical steroid is not limited and is at the discretion of the treating physician as are dosing and concomitant treatments. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adrenal suppression | Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use | 3 months |
| Adrenal suppression | Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use | 12 months |
| Growth failure | Rates of decreased Height for age after 12 months of treatment. | 12 months |
| Growth failure | Rates of decreased Height for age after 12 months of treatment. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density | Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA) | 12 months |
| Bone mineral density | Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA) |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients diagnosed with eosinophilic esophagitis for whom following discussion between the patient/gaurdians and physician treatment with topical steroids are planned.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens Children's Hospital "AGIA SOPHIA" | Athens | 115 27 | Greece | |||
| Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28507746 | Background | Lucendo AJ, Molina-Infante J, Arias A, von Arnim U, Bredenoord AJ, Bussmann C, Amil Dias J, Bove M, Gonzalez-Cervera J, Larsson H, Miehlke S, Papadopoulou A, Rodriguez-Sanchez J, Ravelli A, Ronkainen J, Santander C, Schoepfer AM, Storr MA, Terreehorst I, Straumann A, Attwood SE. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017 Apr;5(3):335-358. doi: 10.1177/2050640616689525. Epub 2017 Jan 23. | |
| 29062584 |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 3 years |
| Hyperglycemia | Rates of elevated fasting glucose after 3 and 12 months of treatment | 3 months |
| Hyperglycemia | Rates of elevated fasting glucose after 3 and 12 months of treatment | 12 months |
| Elevated Liver Enzymes | Elevated ALT | 3 months |
| Histological remission 3 months | Histological remission at endoscopy timepoints | 3 months |
| Histological remission 12 months | Histological remission at endoscopy timepoints | 12 months |
| Clinical remission | Clinical remission at endoscopy time points according to PEESS v.2 | 3 months |
| Clinical remission | Clinical remission at endoscopy time points according to PEESS v.2 | 12 months |
| Petah Tikva |
| 49202 |
| Israel |
| Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli" | Naples | Italy |
| Maternal and Child Health Department, Sapienza | Rome | Italy |
| Background |
| Hsu S, Wood C, Pan Z, Rahat H, Zeitler P, Fleischer D, Menard-Katcher C, Furuta GT, Atkins D. Adrenal Insufficiency in Pediatric Eosinophilic Esophagitis Patients Treated with Swallowed Topical Steroids. Pediatr Allergy Immunol Pulmonol. 2017 Sep 1;30(3):135-140. doi: 10.1089/ped.2017.0779. |
| 26687577 | Background | Golekoh MC, Hornung LN, Mukkada VA, Khoury JC, Putnam PE, Backeljauw PF. Adrenal Insufficiency after Chronic Swallowed Glucocorticoid Therapy for Eosinophilic Esophagitis. J Pediatr. 2016 Mar;170:240-5. doi: 10.1016/j.jpeds.2015.11.026. Epub 2015 Dec 11. |
| 27004676 | Background | Harel S, Hursh BE, Chan ES, Avinashi V, Panagiotopoulos C. Adrenal insufficiency exists for both swallowed budesonide and fluticasone propionate in the treatment of eosinophilic esophagitis. J Pediatr. 2016 Jul;174:281. doi: 10.1016/j.jpeds.2016.02.056. Epub 2016 Mar 19. No abstract available. |
| 29508432 | Background | Philpott H, Dougherty MK, Reed CC, Caldwell M, Kirk D, Torpy DJ, Dellon ES. Systematic review: adrenal insufficiency secondary to swallowed topical corticosteroids in eosinophilic oesophagitis. Aliment Pharmacol Ther. 2018 Apr;47(8):1071-1078. doi: 10.1111/apt.14573. Epub 2018 Mar 5. |
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |