Molecular Basis of Food Allergy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Hospital of Philadelphia
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Jonathan Spergel, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01832324
First received: April 12, 2013
Last updated: April 22, 2014
Last verified: April 2014
  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
Food Protein Induced Enterocolitis

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

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: 1000
Study Start Date: January 2011
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Months to 75 Years
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:

  • Food Allergy

    • Eosinophilic Esophagitis confirmed on upper endoscopy and biopsy per current consensus guidelines
    • Food Protein Induced Enterocolitis

Exclusion Criteria:

  • Refusal to Sign Consents -- Conditions that do not allow for blood draws
  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: Megan Ott foodallergyresearch@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadephia, Pennsylvania, United States, 19104
Contact: Courtney Rooney       rooneyc@email.chop.edu   
Principal Investigator: Jonathan M Spergel, MD, PhD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Investigators
Principal Investigator: Jonathan M Spergel, MD, PhD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Jonathan Spergel, Professor of Pediatrics, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01832324     History of Changes
Other Study ID Numbers: CHOP IRB 005998
Study First Received: April 12, 2013
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014