Antihistamines in Eosinophilic Esophagitis (ATEE)

Mayo Clinic

Status and phase: Terminated; Phase 2

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Loratadine; Drug: Placebo; Drug: Famotidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04248712

19-005510

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.

Treatment:

Drug: Loratadine

Drug: Famotidine

Placebo Group

Placebo Comparator group

Description:

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:

Drug: Placebo