NCT01821898

Eosinophilic Esophagitis Clinical Therapy Comparison Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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: 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."

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).

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Oral Budesonide	This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day
OTHER	Elimination diet	This group will receive an elimination diet

Timeline

• Start date: 2013-07-09
• Primary completion: 2018-09-24
• Completion: 2018-09-24
• First posted: 2013-04-01
• Last updated: 2021-01-11
• Results posted: 2021-01-11

Locations

1 site across 1 country: United States