Clinical trial NCT05444543: Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
Official title: Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eosinophilic Esophagitis
Keywords: Fluticasone
Budesonide
Adolescent
Cycling
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 23
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent of Patients in Remission at One Year as Measured by EGD
timeFrame: up to one year
Secondary outcomes:
measure: Number of Patients Who Report Adverse Events as Measured by Patient Report
timeFrame: up to 12 months
measure: Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work
timeFrame: up to 12 months
Other outcomes:
measure: Change in Quality of Life as Measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Percent of Patients With Elevated IL-13 as Measured by Biopsy
timeFrame: up to 12 months
measure: Percent of Patients With Elevated Eotaxin as Measured by Biopsy
timeFrame: up to 12 months
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Thomas Sferra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Nuphar Lendner, MD
role: PRINCIPAL_INVESTIGATOR
References: