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: 1. 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 2. 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."
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day
This group will receive an elimination diet
Texas Children's Hospital
Houston, Texas, United States
Peak Number of Eosinophils/High Powered Field
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
Time frame: 16 weeks
Quality of Life Survey Score
PedsQL total survey score to assess overall quality of life before and after treatment
Time frame: 16 weeks
Symptom Score
Assess the subject's symptoms using the validated tool termed Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module by measuring % of normal bolus transit swallow and % of normal peristaltic esophageal body contractions.
Time frame: 16 weeks
Exploratory Studies
Proteomic studies search for certain proteins in the blood that may be linked to active EoE. Immune analysis will help identify better methods for diagnosis, treatment, and prevention of immune system changes leading to diseases.
Time frame: Conclusion of study
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