Official Title
Molecular Basis of Food Allergy and Food Tolerance
Brief Title
Molecular Basis of Food Allergy
Protocol ID
NCT01832324
Lead Sponsor
Children's Hospital of Philadelphia
Brief Summary
The Study examines the molecular basis of food allergy. It explores the interaction
between T cells, InKT cells, basophils and cytokines in the development of food allergy.
The study also explores these factors in development of tolerance "outgrowing" food
allergy. It will also explore the genetic factors that lead to the development of food
allergy.
The study examines all type of food allergy including IgE mediated reactions,
Eosinophilic Esophagitis and Food Protein Induced Enterocolitis
Detailed Description
Food Allergy (FA) is a common pediatric atopic disease. Characteristically children
affected by FA become sensitized to food in the first few months of life and
spontaneously outgrow the disease by 5-6 years of age in about 80% of cases. At the
present time, diagnosis of FA is made by a combination of history, skin testing and food
challenge. The pathogenic mechanisms leading to food sensitization and subsequent
spontaneous tolerance development are not understood.
Enrollment Count
5,300 participants
Eligibility Criteria
Inclusion Criteria for Study Group:
1. Males or females age 1 month to 65 years.
2. Diagnosis of Food Allergy. Food Allergy can be either IgE or non-IgE mediated food
allergy including Eosinophilic Esophagitis and Food Protein Induced Enterocolitis.
Inclusion Criteria for Control group:
1. Age and sex matched patients without food allergies
2. Sibling and parents of patients with food allergies
Inclusion Criteria for Control group with atopy:
1. Age and sex matched patients without food allergies
2. Sibling and parents of patients with food allergies
3. Patients with atopy
Exclusion Criteria
1. Underlying disease or medical problem that is judged to serious or risky to allow 3
ml/kg of blood to be drawn from a vein (such as serious anemia, cancer, poor vein
abscess, serious infections).
2. Subjects that do not meet the enrollment criteria may not be enrolled. Any
violations of these criteria will be reported in accordance with Institutional
Review Board (IRB) policies and procedures study procedures.
Filters
Food Allergy
Eosinophilic Esophagitis
ENROLLING_BY_INVITATION
CHILD
ADULT
OLDER_ADULT