Eosinophilic Esophagitis Clinical Trial
Official title:
Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders
Background:
- Food allergies are characterized by abnormal immune system responses to certain foods, such
as peanuts, strawberries, and shellfish. Some individuals with these allergies have immediate
allergic reactions on contact with the food in question and need immediate treatment to
prevent severe complications. In contrast, eosinophil-associated gastrointestinal disorders
are related disorders in which white blood cells in the intestinal tract react to certain
foods, causing abdominal pain, nausea, and other digestion problems. Researchers are
interested in studying these conditions to better understand how the immune system responds
to food allergies.
Objectives:
- To examine how the immune system responds to food allergens.
- To examine how certain white blood cells contribute to disease in individuals with food
allergies and other inflammatory diseases.
Eligibility:
- Individuals between 18 and 65 years of age who have a history of (a) severe allergic
reaction to peanuts (and have peanut-specific antibodies), (b) allergy or inflammatory
disease, or (c) eosinophil-associated gastrointestinal disorder (with at least two
documented food allergies).
- Healthy volunteers between 18 and 65 years of age who have no known allergies or asthma.
Design:
- All participants will have a screening visit and a procedure visit. The procedure visit
will take place within 30 to 60 days of the screening visit, and will take 3 to 4 hours
depending on the procedure(s) done.
- Participants will be screened with a physical examination and medical history, and will
provide blood samples for testing. Participants with peanut or other allergies will have
additional tests to determine their levels of sensitivity to certain foods. Participants
with eosinophil-associated gastrointestinal disorder will provide stool samples for
testing.
- At the procedure visit, participants with peanut allergies and participants with other
allergies will provide blood samples and have leukapherisis to collect white blood cells
for examination.
- At the procedure visit, healthy volunteers and participants with eosinophil-associated
gastrointestinal disorder will provide blood samples and have leukapherisis to collect
white blood cells for examination. In addition, some but not all of these participants
will have a procedure called esophagogastroduodenoscopy (EGD), which will examine the
esophagus, stomach, and small intestine. Participants who are scheduled to have EGD will
be asked to fast for 6 hours before the procedure.
Food allergy refers to a number of disorders characterized by clinical diseases associated
with abnormal immune responses to food antigens. Classical IgE mediated anaphylactic food
allergy is characterized by immediate hypersensitivity, and has a prevalence of approximately
6% and 3% in children and adults, respectively. In contrast, eosinophil associated
gastrointestinal disorders (EGIDs), including eosinophilic esophagitis (EoE) and eosinophilic
gastroenteritis (EG), are food allergy associated disorders characterized by eosinophilic
inflammation of the gut, typically without anaphylaxis. Progress in the treatment and
management of these food allergies requires further understanding of the immunological
pathogenesis of these disorders. A subset of peripheral blood food allergen specific
interleukin (IL) -5 producing T cells that are present in EGID but not peanut allergic
subjects has recently been characterized. The primary objective of this study is to determine
if similar IL-5 producing T cells are present in the gut of EGID subjects. To this end, both
EGID and healthy non-allergic subjects will be enrolled and gastrointestinal biopsies will be
obtained for intracellular cytokine staining, RT-PCR and ELISA.
Additionally, this protocol will supply blood and leukapheresis samples for exploratory
studies on immunologic mechanisms underlying anaphylactic food allergy and EGIDs. A total of
up to 400 subjects recruited from outside physician referrals and support groups, as well as
from those in existing National Institutes of Health (NIH) protocols will be enrolled in this
Clinical Center study.
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