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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05444543
Other study ID # STUDY20210671
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 17, 2021
Est. completion date October 13, 2023

Study information

Verified date January 2024
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fluticasone Propionate
Participants will cycle topical steroid in a three-months on three-months off fashion
Budesonide
Participants will cycle topical steroid in a three-months on three-months off fashion

Locations

Country Name City State
United States University Hospitals Cleveland Medical Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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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