NCT01832324|Enrolling By Invitation
Loading search results
Sponsor study identifier
observational
5,300
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 12, 2013
Actual (reported)April 16, 2013
Actual (reported)November 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Food Allergy (Both IgE and Non-IgE Mediated) Atopic Controls Healthy controls
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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.
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.
DNA, sera and PBMC
Jonathan M Spergel, MD, PhD
Children's Hospital of Philadelphia
First Submitted
April 12, 2013
First Posted
April 16, 2013
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2030
EstimatedTherapeutic Effect of Chinese Herbal Medicine on Food Allergy
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
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 21, 2026
Record last verified: 2026-09
Deidentiifed data including specific IgE, results of basophil assay and what individual food that the patient is reacting to will be included.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: