Antihistamines in Eosinophilic Esophagitis

Phase 2

Terminated

Brief Summary: Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.

Detailed Description: The purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. Antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. The two antihistamines used in this study are loratadine and famotidine.

Recruitment & Eligibility

Inclusion Criteria

Patients over the age of 18, male and female.
Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal biopsies obtained within 6 months prior to enrollment (>15 eosinophils per hpf on at least 2 esophageal levels)
Subjects must be able to give appropriate informed consent

Exclusion Criteria

Not willing or able to sign consent.
Patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks.
Patients who have been treated with acid-suppressing medications (PPI or H2 receptor antagonists) in the previous 6 weeks.
Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.
Patients with known allergies or hypersensitivity to anti-histamines.
Patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
Patients who are pregnant.

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
Treatment Group	Famotidine	Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
Treatment Group	Loratadine	Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Adverse Events	12 weeks	Number of adverse events reported
Change in Maximum Eosinophil Count	12 weeks	Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire	12 weeks	Measured by the self-reported Dysphagia Symptom Questionnaire (DSQ). The DSQ ranges from 0 to 10, with a lower score indicating less symptoms and a higher score indicating more symptoms.
Change in Endoscopic Response, as Measured by the Endoscopic Reference Score	12 weeks	Percentage of subjects with endoscopic response as measured by the Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis.
Change in Histologic Response	12 weeks	Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus