Eosinophilic Esophagitis Clinical Therapy Comparison Trial

December 16, 2020 updated by: Carla McGuire Davis, Baylor College of Medicine

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."

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Signed written informed consent and assent if applicable prior to performing any study specific procedure.
  2. Male or female subjects aged 3-17 years old.
  3. Diagnosis of EoE within 2 months of enrollment (greater than or equal to 15 eosinophils per high powered field in both proximal or distal esophageal specimens).
  4. Subjects who have failed at least a two month trial of proton pump inhibitor.
  5. A female subject of childbearing potential who is or may become sexually active agrees to routinely use contraception from the time of signing informed consent and assent until 30 days from end of study.
  6. Positive allergy testing on prick and/or patch testing.

Exclusion Criteria

  1. Subjects who are responsive to at least a two month trial of a proton pump inhibitor.
  2. Diagnosis of Inflammatory Bowel Disease or static encephalopathy.
  3. Prior abdominal surgery and other organ disorder not including atopic diseases.
  4. Previous esophageal surgical procedure.
  5. Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia.
  6. Positive for pregnancy.
  7. Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary elimination of major allergens
  8. Presence of increased eosinophils in the stomach, small intestine, large intestine, and colon based on Debrosse et al.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Positive for food allergy: Group A
Oral Budesonide
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 Names:
  • Steroid
ACTIVE_COMPARATOR: Positive for food allergy: Group B
Elimination diet
Other: Elimination diet
This group will receive an elimination diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Survey Score
Time Frame: 16 weeks
PedsQL total survey score to assess overall quality of life before and after treatment
16 weeks
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.
16 weeks
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.
Conclusion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Carla M. Davis, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2013

Primary Completion (ACTUAL)

September 24, 2018

Study Completion (ACTUAL)

September 24, 2018

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (ESTIMATE)

April 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2021

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-27999
  • 36533 (OTHER_GRANT: American Academy of Allergy, Asthama and Immunology)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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