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

NCT ID: NCT05444543

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2023-10-13

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Participants in this arm will continue with their normal standard of care regimen of daily topical steroids

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion

Group Type: EXPERIMENTAL

Fluticasone Propionate

Intervention Type: DRUG

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

Budesonide

Intervention Type: DRUG

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

Interventions

Fluticasone Propionate

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

Intervention Type: DRUG

Budesonide

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Thomas J Sferra, MD

Chief of Pediatric Gastroenterology Hepatology and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Sferra, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Nuphar Lendner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY20210671

Identifier Type: -

Identifier Source: org_study_id