Molecular Basis of Food Allergy

NCT01832324 | Enrolling By Invitation

• 1 other identifier: 08-005998
• Study Type: observational
• Target: 5,300
• Locations: 1 country
• Sites: 1

Brief Summary

The Study examines the molecular basis of food allergy. It explores the interaction between T cells, InKT cells, basophils 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

Conditions

Food Allergy; Eosinophilic Esophagitis

Keywords

Food Allergy; Eosinophilic Esophagitis; Food Protein Induced Enterocolitis; iNKT Cells; T cells

Outcome Measures

Primary Outcomes (3)

• Blood sample for mechanistic studies:

  Blood will be obtained by venipuncture. The blood samples will be used to estimate the frequency of to estimate the frequency and the products of cells involved in the allergic reaction. We will quantify the number of lymphocytes and their subsets, and the number granulocytes (neutrophils, basophils, and eosinophils) and monocytes and we will analyze their products (such as cytokines, chemokines, prostanoids). Such analysis will be performed doing cytoflow studies, using 4 color flow cytometry (BD FACSCalibur Flow XCytometry System) at the Children's Hospital Flow Cytometry core facilities, ELISA, mRNA analysis and western blots using when indicated the Nucleic Acid/Protein Core. If blood won't be all used up in the aforementioned tests it will be stored in nitrogen liquid for future similar tests or repetition of the ones already performed in case of technical problem with the first attempt.

  1 year

• Blood sample for genetic study (optional)

  The Center for Applied Genomics (CAG) will perform genetic analysis. All subjects (cases and controls) have been or will be genotyped on the Illumina HumanHap BeadArray SNP platform, and data has been stored in following an IRB approved protocol Whole Exon Sequencing (also known as targeted exome capture) is an efficient strategy to selectively sequence the coding regions of the genome as a cheaper but still effective alternative to whole genome sequencing. Exons are short, functionally important sequences of DNA which represent the regions in genes that are translated into protein and the untranslated region flanking them (UTR). It is estimated that the protein coding regions of the human genome constitute about 85% of the disease-causing mutations. Statistical analysis will be done in conjunction with CAG and Children's Hospital of Philadelphia (CHOP) bioinformatics center. We will compare the genetic variants identified between sequencing and SNPs -based genotyping.

  1 year

• EndoPat Test (optional)

  EndoPat is a noninvasive endothelial function assessment. Patient should rest comfortably for 10 minutes prior to the test. Using a standard blood pressure cuff, the brachial artery is occluded for a 5 minute period. When the cuff is released, EndoPat measures blood flow rates pre-occlusion and post-occlusion. This test requires patients to sit still for 15 minutes. It's recommended that the patient fast 3 to 8 hours before the test. In addition, the following drugs should not be used for 24 hours before testing: Nitroglycerine, Alpha-blockers, beta-blockers, and calcium channel blockers, ACE inhibitors, Statins

  1 year

Eligibility Criteria

• Age: 1 Month - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Food Allergy (Both IgE and Non-IgE Mediated) Atopic Controls Healthy controls

You may qualify if:

• 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.
• Age and sex matched patients without food allergies
• Sibling and parents of patients with food allergies
• Age and sex matched patients without food allergies
• Sibling and parents of patients with food allergies
• Patients with atopy

You may not qualify if:

• 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 Institutional Review Board (IRB) policies and procedures study procedures.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Ruffner MA, Zhang Z, Maurer K, Muir AB, Cianferoni A, Sullivan KE, Spergel JM. RNA sequencing identifies global transcriptional changes in peripheral CD4+ cells during active oesophagitis and following epicutaneous immunotherapy in eosinophilic oesophagitis. Clin Transl Immunology. 2021 Jul 22;10(7):e1314. doi: 10.1002/cti2.1314. eCollection 2021.

  PMID: 34322233 BACKGROUND

• Dilollo J, Rodriguez-Lopez EM, Wilkey L, Martin EK, Spergel JM, Hill DA. Peripheral markers of allergen-specific immune activation predict clinical allergy in eosinophilic esophagitis. Allergy. 2021 Nov;76(11):3470-3478. doi: 10.1111/all.14854. Epub 2021 May 14.

  PMID: 33840099 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA, sera and PBMC

MeSH Terms

Conditions

Food Hypersensitivity; Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jonathan M Spergel, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 16, 2013
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)