Status:
COMPLETED
Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
Lead Sponsor:
Tufts Medical Center
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
7-65 years
Brief Summary
There is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (EoE), a chronic allergic diseases characterized by significant infiltration of eosinophils in the esophagus. Because...
Eligibility Criteria
Inclusion
- Age 7-65.
- Confirmed diagnosis of EoE. The diagnosis of eosinophilic esophagitis is based upon the presence of characteristic clinical features and large numbers of eosinophils in the esophagus on pathologic examination (≥15 eosinophils per high powered \[400x\] field in at least one specimen) despite acid suppression with a PPI for one to two months. The criteria also include normal gastric and duodenal mucosal biopsies and the exclusion of other causes. Clinical features in adults include dysphagia, pain and/or history of food impaction. Symptoms in children vary depending in part upon their age: feeding disorders (median age 2.0), vomiting (median age 8.1), abdominal pain (median age 12.0), dysphagia (median age 13.4), and food impaction (median age 16.8).
Exclusion
- Use of systemic or inhaled corticosteroids in the preceding 3 months.
- History of doctor-diagnosed asthma, acute or chronic rhinosinusitis.
- History of cirrhosis.
- History of kidney, heart or lung disease.
- Pregnancy
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01170234
Start Date
August 1 2010
End Date
February 1 2012
Last Update
April 16 2019
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111