Montelukast in the Treatment of Duodenal Eosinophilia
Eosinophilic Gastroenteritis, Dyspepsia
About this trial
This is an interventional treatment trial for Eosinophilic Gastroenteritis focused on measuring dyspepsia, eosinophilic gastroenteritis, montelukast
Eligibility Criteria
Inclusion Criteria: A subject will be eligible for inclusion in this study if all of the following criteria are met: Patients with dyspepsia defined as upper abdominal pain or discomfort of at least two months duration. Male and female subjects 6 - 17 years of age Endoscopic mucosal biopsies revealing at least 20 eosinophils in a high power field on specimens from the duodenum in the absence of other defined duodenal pathology. Written informed consent signed by the subject's legal guardian and by the investigator and patient assent. Exclusion Criteria: Subjects will not be eligible for inclusion in this study if any of the following criteria apply: A subject who has previously been treated with montelukast. Treatment with steroids or oral cromolyn in the four weeks prior to endoscopy or during the study. Any history, clinical, and/or biochemical evidence of clinically significant renal or liver disease. Treatment with any inducers or inhibitors of CYP3A4. Intake of grapefruit juice or oral vitamin E supplementation
Sites / Locations
- Children's Mercy Hospital and Clinics