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Molecular Basis of Food Allergy

This study is currently recruiting participants.
Verified December 2016 by Children's Hospital of Philadelphia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832324
First Posted: April 16, 2013
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Pennsylvania
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  Purpose

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
Food Allergy Eosinophilic Esophagitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Basis of Food Allergy and Food Tolerance

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • T cell Phenotype in Patients with Food Allergy [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
DNA, sera and PBMC

Estimated Enrollment: 1300
Study Start Date: January 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 65 Years   (Child, 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:

  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 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
Philadephia, 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 Submitted: April 12, 2013
First Posted: April 16, 2013
Last Update Posted: December 6, 2016
Last Verified: December 2016
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