Clinical Trial: Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Eosinophilic Esophagitis Clinical Therapy Comparison Trial

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:

  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 Summary:

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 60 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).


Sponsor: Baylor College of Medicine

Current Primary Outcome: EoE Score [ Time Frame: 16 weeks ]

Primary outcome will be the EoE endoscopy score (eosinophil/high powered field) on repeat biopsy after the treatment phase.


Original Primary Outcome: EoE Score [ Time Frame: 8 weeks ]

Primary outcome will be the EoE endoscopy score (eosinophil/high powered field) on repeat biopsy after the treatment phase.


Current Secondary Outcome:

  • Quality of Life [ Time Frame: 16 weeks ]
    PedsQL to assess overall quality of life.
  • Symptom score [ Time Frame: 16 weeks ]
    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.
  • Exploratory studies [ Time Frame: Conclusion of study ]
    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.


Original Secondary Outcome:

  • Quality of Life [ Time Frame: 8 weeks ]
    PedsQL to assess overall quality of life.
  • Symptom score [ Time Frame: 8 weeks ]
    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.
  • Exploratory Proteomic and immune analysis [ Time Frame: 8 weeks ]
    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.


Information By: Baylor College of Medicine

Dates:
Date Received: March 27, 2013
Date Started: March 2013
Date Completion: March 2018
Last Updated: August 1, 2016
Last Verified: August 2016