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Completed

NCT Number: NCT05444543

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

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.

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

Participants will cycle topical steroid in a three-months on three-months off fashion

Budesonide

Drug

Participants will cycle topical steroid in a three-months on three-months off fashion

Primary outcomes

  1. Percent of Patients in Remission at One Year as Measured by EGD

    Time frame: up to one year

    The outcome measure is the number of participants who maintained remission (less than or equal to 15 eosinophils per high powered field in esophageal biopsies) for one year after demonstration of a therapeutic effect of topical steroid therapy.

Secondary outcomes

  1. Number of Patients Who Report Adverse Events as Measured by Patient Report

    Time frame: up to 12 months

  2. Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work

    Time frame: up to 12 months

    Subclinical adrenal insufficiency was defined as a morning cortisol level less than 10.0 micrograms per deciliter. One low level at anytime during the study period was recorded as an insufficient level.

Other outcomes

  1. Change in Quality of Life as Measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content

    Time frame: Baseline, 3 months, 6 months, 12 months

    14 item questionnaire where patients either agree or disagree

  2. Percent of Patients With Elevated IL-13 as Measured by Biopsy

    Time frame: up to 12 months

  3. Percent of Patients With Elevated Eotaxin as Measured by Biopsy

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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