Molecular Basis of Food Allergy
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ClinicalTrials.gov Identifier: NCT01832324 |
Recruitment Status
:
Recruiting
First Posted
: April 16, 2013
Last Update Posted
: December 8, 2017
|
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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 |
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 2018 |
Estimated Study Completion Date : | December 2019 |
- T cell Phenotype in Patients with Food Allergy [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA

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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 |
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.

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
Contact: Deirdre Burke | burked2@email.chop.edu |
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 |
Principal Investigator: | Jonathan M Spergel, MD, PhD | Children's Hospital of Philadelphia |
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: | December 8, 2017 |
Last Verified: | December 2017 |
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 |