Molecular Basis of Food Allergy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Children's Hospital of Philadelphia
Sponsor:
Collaborators:
University of Pennsylvania
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01832324
First received: April 12, 2013
Last updated: June 3, 2016
Last verified: June 2016
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Month to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 12, 2013
Last Updated: June 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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:
Food Hypersensitivity
Hypersensitivity
Esophagitis
Eosinophilic Esophagitis
Immune System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 28, 2016