Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Baylor College of Medicine
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Peak Number of Eosinophils/High Powered Field
Study Overview
Brief Summary
Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and poor growth or weight loss in children
The main purpose of this research study is to compare the effectiveness of two different types of treatment for EoE:
- Oral viscous budesonide- which is a steroid medication that has been used to treat asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation in EoE, and
- Specific food elimination.
The study will also be looking to see if a blood test is useful in following the progression of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more "invasive test."
Detailed Description
This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet.
A total of 40 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks.
The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments.
Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height.
Group B will receive an elimination diet (elimination of the foods the subject is allergic to).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Positive for food allergy: Group A
Oral Budesonide
Intervention: Oral Budesonide (Drug)
Positive for food allergy: Group B
Elimination diet
Intervention: Elimination diet (Other)
Outcomes
Primary Outcomes
Peak Number of Eosinophils/High Powered Field
Time Frame: 16 weeks
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
Secondary Outcomes
- Symptom Score(16 weeks)
- Quality of Life Survey Score(16 weeks)
- Exploratory Studies(Conclusion of study)
Investigators
Carla McGuire Davis
Assistant Professor
Baylor College of Medicine