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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:
Children's Hospital of Philadelphia
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: December 5, 2016
Last verified: December 2016
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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) |
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) |
| 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
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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
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | April 12, 2013 |
| Last Updated: | December 5, 2016 |
| 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:
|
Eosinophilic Esophagitis Hypersensitivity Esophagitis Food Hypersensitivity Immune System Diseases Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Gastroenteritis Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on June 23, 2017