Prevalence of Food Allergies in a Cohort of Adult Patients With Eosinophilic Esophagitis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | May 2011 |
| End Date: | July 2014 |
Eosinophilic esophagitis is characterized by an eosinophilic infiltration of the esophagus.
It presents clinically with a variety of symptoms including dysphagia, emesis, and food
impaction. Although the underlying mechanism is different, gastroesophageal reflux can
present with similar clinical findings but can be distinguished from eosinophilic esophagitis
by the number of eosinophils present on esophageal biopsy. In children, food allergies play a
role in exacerbating eosinophilic esophagitis, but the role of food allergies in adults is
uncertain. In this study, we aim to determine the prevalence of food allergies in a cohort of
adults with eosinophilic esophagitis.
It presents clinically with a variety of symptoms including dysphagia, emesis, and food
impaction. Although the underlying mechanism is different, gastroesophageal reflux can
present with similar clinical findings but can be distinguished from eosinophilic esophagitis
by the number of eosinophils present on esophageal biopsy. In children, food allergies play a
role in exacerbating eosinophilic esophagitis, but the role of food allergies in adults is
uncertain. In this study, we aim to determine the prevalence of food allergies in a cohort of
adults with eosinophilic esophagitis.
Study Population Male and female subjects, ages 18 years and older with findings of > 15
eosinophils per high powered field by endoscopic esophageal biopsy. Patients should also have
symptoms consistent with eosinophilic esophagitis including dysphagia, heartburn, epigastric
pain, recurrent vomiting, or food impaction. The comparative group will include male and
female subjects, ages 18 years and older with a previous diagnosis of gastroesophageal reflux
with findings of < 15 eosinophils per high power field by endoscopic esophageal biopsy.
Inclusion Criteria
1. Male and female subjects 18 years and older
2. Previous diagnosis of eosinophilic esophagitis with clinical symptoms including
heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as
well > 15 eosinophils per high powered field (400x magnification) by endoscopic
esophageal biopsy in both the proximal and distal esophagus
3. Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered
field (400x magnification) by endoscopic biopsy
Exclusion Criteria
1. Male and female subjects less than 18 years of age
2. Pregnant female subjects
3. Subjects who are receiving systemic steroids and are unable to stop prior to enrollment
4. Subjects who are receiving systemic antihistamines and are unable to stop prior to
enrollment
5. Subjects who are unable to cooperate/comply with study procedures or communicate with
investigator in order to successfully complete the study
6. Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or
psoriasis who would be unable to complete skin or patch testing
7. Subjects with an infirmity, disability, or geographical location which seems likely to
prevent regular attendance for patient visit Risks Skin testing with prick methodology
has a risk of systemic reaction of less than 0.1% per 40 tests, however, no deaths have
been reported with this method of testing. Systemic reactions are readily treated using
Injectable epinephrine with oral antihistamines and oral corticosteroids (prednisone).
Patch testing has no known associated risk for development of systemic reactions.
Phlebotomy is associated with a minimal risk of bleeding, significant local discomfort,
and infection from the needle puncture.
Benefits Treatment options for adults with eosinophilic esophagitis are limited. Food
allergies are a known contributor to this disorder in children and a better understanding of
food allergies in adult subjects may provide additional treatment options.
Adverse Events and Withdrawal Criteria All subjects will be assessed for adverse events at
each study visit. If any adverse events are experienced by the subject, the investigator will
document the event within the subject's file and promptly report the event to the IRB. The
investigators involved with this study will determine if a participant needs to be withdrawn
from the study based upon the subject's health and medical history.
Sample Size Sample size estimation is based on the assumption that up to 50% of adults with
eosinophilic esophagitis (EE) will have a positive skin test to food and 10% of adults
without EE will have a positive skin test to food. With this assumption, a total of 40
subjects are needed, 20 per group, in order to achieve at least 80% power with two sided test
at alpha level of 0.05 and beta 0.2.
eosinophils per high powered field by endoscopic esophageal biopsy. Patients should also have
symptoms consistent with eosinophilic esophagitis including dysphagia, heartburn, epigastric
pain, recurrent vomiting, or food impaction. The comparative group will include male and
female subjects, ages 18 years and older with a previous diagnosis of gastroesophageal reflux
with findings of < 15 eosinophils per high power field by endoscopic esophageal biopsy.
Inclusion Criteria
1. Male and female subjects 18 years and older
2. Previous diagnosis of eosinophilic esophagitis with clinical symptoms including
heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as
well > 15 eosinophils per high powered field (400x magnification) by endoscopic
esophageal biopsy in both the proximal and distal esophagus
3. Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered
field (400x magnification) by endoscopic biopsy
Exclusion Criteria
1. Male and female subjects less than 18 years of age
2. Pregnant female subjects
3. Subjects who are receiving systemic steroids and are unable to stop prior to enrollment
4. Subjects who are receiving systemic antihistamines and are unable to stop prior to
enrollment
5. Subjects who are unable to cooperate/comply with study procedures or communicate with
investigator in order to successfully complete the study
6. Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or
psoriasis who would be unable to complete skin or patch testing
7. Subjects with an infirmity, disability, or geographical location which seems likely to
prevent regular attendance for patient visit Risks Skin testing with prick methodology
has a risk of systemic reaction of less than 0.1% per 40 tests, however, no deaths have
been reported with this method of testing. Systemic reactions are readily treated using
Injectable epinephrine with oral antihistamines and oral corticosteroids (prednisone).
Patch testing has no known associated risk for development of systemic reactions.
Phlebotomy is associated with a minimal risk of bleeding, significant local discomfort,
and infection from the needle puncture.
Benefits Treatment options for adults with eosinophilic esophagitis are limited. Food
allergies are a known contributor to this disorder in children and a better understanding of
food allergies in adult subjects may provide additional treatment options.
Adverse Events and Withdrawal Criteria All subjects will be assessed for adverse events at
each study visit. If any adverse events are experienced by the subject, the investigator will
document the event within the subject's file and promptly report the event to the IRB. The
investigators involved with this study will determine if a participant needs to be withdrawn
from the study based upon the subject's health and medical history.
Sample Size Sample size estimation is based on the assumption that up to 50% of adults with
eosinophilic esophagitis (EE) will have a positive skin test to food and 10% of adults
without EE will have a positive skin test to food. With this assumption, a total of 40
subjects are needed, 20 per group, in order to achieve at least 80% power with two sided test
at alpha level of 0.05 and beta 0.2.
Inclusion Criteria:
1. Male and female subjects 18 years and older
2. Previous diagnosis of eosinophilic esophagitis with clinical symptoms including
heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as
well > 15 eosinophils per high powered field (400x magnification) by endoscopic
esophageal biopsy in both the proximal and distal esophagus
3. Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered
field (400x magnification) by endoscopic biopsy
Exclusion Criteria:
1. Male and female subjects less than 18 years of age 2. Pregnant female subjects 3.
Subjects who are receiving systemic steroids and are unable to stop prior to enrollment 4.
Subjects who are receiving systemic antihistamines and are unable to stop prior to
enrollment 5. Subjects who are unable to cooperate/comply with study procedures or
communicate with investigator in order to successfully complete the study 6. Subjects with
severe skin disorders such as atopic dermatitis, dermatographism, or psoriasis who would be
unable to complete skin or patch testing 7. Subjects with an infirmity, disability, or
geographical location which seems likely to prevent regular attendance for patient visit
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