Eosinophilic Esophagitis Clinical Trial
Official title:
Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis
Verified date | January 2024 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of our research study is to assess whether patients with EoE who have achieved control of their disease on topical Fluticasone or Budesonide are able to cycle or take breaks from their treatment with continued remission of their EoE. There will be 30 participants enrolled in this study. There will be 15 patients who will stay on steroid therapy every day and 15 patients who will cycle their steroid therapy on and off to help us compare the two groups. The cycling group will cycle their steroid therapy in a three-months on three-months off fashion.
Status | Completed |
Enrollment | 23 |
Est. completion date | October 13, 2023 |
Est. primary completion date | October 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | Inclusion Criteria: - Pediatric patients between 4-18 years of age with EoE followed by the Division of Pediatric Gastroenterology, Hepatology and Nutrition at Rainbow Babies and Children's Hospital - Patients who are currently on treatment with topical corticosteroids and scheduled for an upcoming endoscopy as part of their routine clinical care (to be used as EGD1) within 3 months of enrollment date - Patients who have achieved documented clinical and endoscopic remission using topical steroids as evidenced by EGD Exclusion Criteria: - Patients who are not responsive to topical corticosteroid treatment for their EoE as evidenced by failure to obtain clinical or endoscopic remission on any pervious screening EGD - Patients less than 4 years of age and older than 18 years of age at the time of recruitment - Patients with history of or current diagnosis of esophageal strictures |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in quality of life as measured by Modified-PedsQLâ„¢ Eosinophilic Esophagitis Module Child Self-Report Item Content | 14 item questionnaire where patients either agree or disagree | Baseline, 3 months, 6 months, 12 months | |
Other | Percent of patients with elevated IL-13 as measured by biopsy | up to 12 months | ||
Other | Percent of patients with elevated eotaxin as measured by biopsy | up to 12 months | ||
Other | Percentage of patients who develop subclinical adrenal insufficiency as measured by blood work | up to 12 months | ||
Primary | Percent of patients in remission at one year as measured by EGD | up to one year | ||
Secondary | Percent of patients who report adverse events as measured by patient report | up to 12 months |
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