Status:
TERMINATED
Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Lead Sponsor:
Baylor College of Medicine
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
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 e...
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 re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01821898
Start Date
July 9 2013
End Date
September 24 2018
Last Update
January 11 2021
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030