Molecular Basis of Food Allergy

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ClinicalTrials.gov Identifier: NCT01832324

Recruitment Status : Recruiting

First Posted : April 16, 2013

Last Update Posted : January 8, 2019

See Contacts and Locations

Sponsor:

Collaborators:

University of Pennsylvania

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Children's Hospital of Philadelphia

Study Description

Brief Summary:

The Study examines the molecular basis of food allergy. It explores the interaction between T cells, InKT cells 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

Condition or disease
Food Allergy Eosinophilic Esophagitis

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.

Study Design


Study Type :	Observational
Estimated Enrollment :	1300 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Molecular Basis of Food Allergy and Food Tolerance
Study Start Date :	January 2011
Estimated Primary Completion Date :	December 2027
Estimated Study Completion Date :	December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Eosinophilic Esophagitis Food Allergy

Genetic and Rare Diseases Information Center resources: Eosinophilic Enteropathy

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

T cell Phenotype in Patients with Food Allergy [ Time Frame: 1 year ]

Biospecimen Retention: Samples With DNA

DNA, sera and PBMC

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	1 Month to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Food Allergy (Both IgE and Non-IgE Mediated) Atopic Controls Healthy controls

Criteria

Inclusion Criteria for Study Group:

Males or females age 1 month to 65 years.
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:

Age and sex matched patients without food allergies
Sibling and parents of patients with food allergies

Inclusion Criteria for Control group with atopy:

Age and sex matched patients without food allergies
Sibling and parents of patients with food allergies
Patients with atopy

Exclusion Criteria

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).
Subjects that do not meet the enrollment criteria may not be enrolled. Any violations of these criteria will be reported in accordance with IRB policies and procedures study procedures.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832324

Contacts


Contact: Deirdre Burke		burked2@email.chop.edu

Locations


United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dierdre Burke burked2@email.chop.edu
Principal Investigator: Jonathan M Spergel, MD, PhD

Sponsors and Collaborators

Children's Hospital of Philadelphia

University of Pennsylvania

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Principal Investigator:	Jonathan M Spergel, MD, PhD	Children's Hospital of Philadelphia

More Information


Responsible Party:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT01832324 History of Changes
Other Study ID Numbers:	08-005998 R01AI097333-01A1 ( U.S. NIH Grant/Contract )
First Posted:	April 16, 2013 Key Record Dates
Last Update Posted:	January 8, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Children's Hospital of Philadelphia:


Food Allergy Eosinophilic Esophagitis Food Protein Induced Enterocolitis iNKT Cells T cells

Additional relevant MeSH terms:


Eosinophilic Esophagitis Hypersensitivity Esophagitis Food Hypersensitivity Immune System Diseases Esophageal Diseases Gastrointestinal Diseases	Digestive System Diseases Gastroenteritis Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate

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