Back to resultsEosinophilic Esophagitis Clinical Therapy Comparison Trial
Primary Purpose
Eosinophilic Esophagitis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral Budesonide
Elimination diet
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophil, Reflux, Esophagus, Food allergy, Trouble Swallowing, Pediatrics
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent and assent if applicable prior to performing any study specific procedure.
- Male or female subjects aged 3-17 years old.
- 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).
- Subjects who have failed at least a two month trial of proton pump inhibitor.
- 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.
- Positive allergy testing on prick and/or patch testing.
Exclusion Criteria
- Subjects who are responsive to at least a two month trial of a proton pump inhibitor.
- Diagnosis of Inflammatory Bowel Disease or static encephalopathy.
- Prior abdominal surgery and other organ disorder not including atopic diseases.
- Previous esophageal surgical procedure.
- Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia.
- Positive for pregnancy.
- Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary elimination of major allergens
- Presence of increased eosinophils in the stomach, small intestine, large intestine, and colon based on Debrosse et al.
Sites / Locations
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Positive for food allergy: Group A
Positive for food allergy: Group B
Arm Description
Oral Budesonide
Elimination diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of Life Survey Score
PedsQL total survey score to assess overall quality of life before and after treatment
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.
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.
Full Information
NCT ID
NCT01821898
First Posted
March 27, 2013
Last Updated
December 16, 2020
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01821898
Brief Title
Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Official Title
Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was below expectation
Study Start Date
July 9, 2013 (Actual)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophil, Reflux, Esophagus, Food allergy, Trouble Swallowing, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive for food allergy: Group A
Arm Type
Active Comparator
Arm Description
Oral Budesonide
Arm Title
Positive for food allergy: Group B
Arm Type
Active Comparator
Arm Description
Elimination diet
Intervention Type
Drug
Intervention Name(s)
Oral Budesonide
Other Intervention Name(s)
Steroid
Intervention Description
This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day
Intervention Type
Other
Intervention Name(s)
Elimination diet
Intervention Description
This group will receive an elimination diet
Primary Outcome Measure Information:
Title
Peak Number of Eosinophils/High Powered Field
Description
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Survey Score
Description
PedsQL total survey score to assess overall quality of life before and after treatment
Time Frame
16 weeks
Title
Symptom Score
Description
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
Title
Exploratory Studies
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Signed written informed consent and assent if applicable prior to performing any study specific procedure.
Male or female subjects aged 3-17 years old.
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).
Subjects who have failed at least a two month trial of proton pump inhibitor.
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.
Positive allergy testing on prick and/or patch testing.
Exclusion Criteria
Subjects who are responsive to at least a two month trial of a proton pump inhibitor.
Diagnosis of Inflammatory Bowel Disease or static encephalopathy.
Prior abdominal surgery and other organ disorder not including atopic diseases.
Previous esophageal surgical procedure.
Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia.
Positive for pregnancy.
Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary elimination of major allergens
Presence of increased eosinophils in the stomach, small intestine, large intestine, and colon based on Debrosse et al.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla M. Davis, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Eosinophilic Esophagitis Clinical Therapy Comparison Trial
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