Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Phase 2

Terminated

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Oral Budesonide; Other: Elimination diet

• Registration Number: NCT01821898
• Lead Sponsor: Baylor College of Medicine

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 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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-01
• Study Start: 2013-07-09
• Primary Completion: 2018-09-24
• Study Completion: 2018-09-24
• Results First Submitted: 2020-02-05
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-16
• Last Update Submitted: 2020-12-16
• Results First Posted: 2021-01-11
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive for food allergy: Group A	Oral Budesonide	Oral Budesonide
Positive for food allergy: Group B	Elimination diet	Elimination diet

Primary Outcome Measures

Name	Time	Method
Peak Number of Eosinophils/High Powered Field	16 weeks	The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.

Secondary Outcome Measures

Name	Time	Method
Symptom Score	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.
Quality of Life Survey Score	16 weeks	PedsQL total survey score to assess overall quality of life before and after treatment
Exploratory Studies	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.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States