Clinical trial NCT01832324: Molecular Basis of Food Allergy
Official title: Molecular Basis of Food Allergy and Food Tolerance
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Food Allergy
Eosinophilic Esophagitis
Keywords: Food Allergy
Eosinophilic Esophagitis
Food Protein Induced Enterocolitis
iNKT Cells
T cells
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Children's Hospital Medical Center, Cincinnati
First posted: 2013-04-16
Enrollment: 5300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Food Allergy (Both IgE and Non-IgE Mediated) Atopic Controls Healthy controls

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.

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.

Primary outcomes:
measure: Blood sample for mechanistic studies:
timeFrame: 1 year
measure: Blood sample for genetic study (optional)
timeFrame: 1 year
measure: EndoPat Test (optional)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jonathan M Spergel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruffner MA, Zhang Z, Maurer K, Muir AB, Cianferoni A, Sullivan KE, Spergel JM. RNA sequencing identifies global transcriptional changes in peripheral CD4+ cells during active oesophagitis and following epicutaneous immunotherapy in eosinophilic oesophagitis. Clin Transl Immunology. 2021 Jul 22;10(7):e1314. doi: 10.1002/cti2.1314. eCollection 2021.
citation: Dilollo J, Rodriguez-Lopez EM, Wilkey L, Martin EK, Spergel JM, Hill DA. Peripheral markers of allergen-specific immune activation predict clinical allergy in eosinophilic esophagitis. Allergy. 2021 Nov;76(11):3470-3478. doi: 10.1111/all.14854. Epub 2021 May 14.