Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Patients over the age of 18, male and female.
- - Patients who carry the diagnosis of 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Dawn Francis, MD|
|Principal Investigator Affiliation||Mayo Clinic|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
Experimental: Treatment Group
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
Placebo Comparator: Placebo Group
Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
Drug: - Famotidine
40 mg tab twice daily by mouth for 12 week duration
Drug: - Loratadine
10 mg tab once daily by mouth for 12 week duration
Drug: - Placebo
Contains no active ingredient
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.