Eosinophilic Esophagitis
Conditions
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.
Interventions
DRUGFamotidine
40 mg tab twice daily by mouth for 12 week duration
DRUGLoratadine
10 mg tab once daily by mouth for 12 week duration
DRUGPlacebo
Contains no active ingredient
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Participants received Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
Famotidine: 40 mg tab twice daily by mouth for 12 week duration
Loratadine: 10 mg tab once daily by mouth for 12 week duration | 1 |
| Placebo Group Participants received Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
Placebo: Contains no active ingredient | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Treatment Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | — | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Adverse Events
Number of adverse events reported
Time frame: 12 weeks
Population: Terminated study due to low enrollment. Data collection \& analysis of Treatment group only. No subjects enrolled in the Placebo group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Adverse Events | 0 adverse events |
Primary
Change in Maximum Eosinophil Count
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.
Time frame: 12 weeks
Population: Terminated study due to low enrollment. No subjects enrolled in the Placebo group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Change in Maximum Eosinophil Count | 0 percentage change |
Secondary
Change in Endoscopic Response, as Measured by the Endoscopic Reference Score
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.
Time frame: 12 weeks
Population: Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group
Secondary
Change in Histologic Response
Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus
Time frame: 12 weeks
Population: Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group
Secondary
Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire
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.
Time frame: 12 weeks
Population: Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group