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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 4 Years - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospitals Cleveland Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Thomas Sferra, MDNuphar Lendner, MD
Principal Investigator Affiliation University Hospitals Cleveland Medical CenterUniversity Hospitals Cleveland Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Arms & Interventions


No Intervention: Control

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

Experimental: Intervention

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


Drug: - Fluticasone Propionate

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

Drug: - Budesonide

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio




University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Site Contact

Nuphar Lendner, MD



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