Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

Eosinophilic Esophagitis Clinical Trial

Official title:

Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444543
• Other study ID #: STUDY20210671
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

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-PedsQL™ 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