Food AllergyNCT01832324
Molecular Basis of Food Allergy
An observational study of Food Allergy and Eosinophilic Esophagitis, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Eosinophilic Esophagitis
- How many people
- 5,300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Food Allergy (Both IgE and Non-IgE Mediated) Atopic Controls Healthy controls
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Molecular Basis of Food Allergy and Food Tolerance
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
Read the detailed description
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.
- Conditions
- Food Allergy, Eosinophilic Esophagitis
- Keywords
- Food Allergy, Eosinophilic Esophagitis, Food Protein Induced Enterocolitis, iNKT Cells, T cells
- Medical subject headings
- Food Hypersensitivity, Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionNov 2030 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan M Spergel, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832324
- Sponsor's protocol ID
- 08-005998
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2013
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Deidentiifed data including specific IgE, results of basophil assay and what individual food that the patient is reacting to will be included.
Publications
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.
PubMed 34322233Dilollo 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.
PubMed 33840099
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Basis of Food Allergy and Food Tolerance
- ClinicalTrials.gov ID
- NCT01832324
- Acronym / sponsor ID
- 08-005998
- Conditions
- Food Allergy, Eosinophilic Esophagitis
- Keywords
- Food Allergy, Eosinophilic Esophagitis, Food Protein Induced Enterocolitis, iNKT Cells, T cells
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,300 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Children's Hospital Medical Center, Cincinnati
- Study start
- Jan 2011
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Food Allergy (Both IgE and Non-IgE Mediated) Atopic Controls Healthy controls
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood sample for mechanistic studies:
Time frame: 1 year
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.
Blood sample for genetic study (optional)
Time frame: 1 year
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.
EndoPat Test (optional)
Time frame: 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 34322233Ruffner 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.
- Background: PubMed 33840099Dilollo 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.
- Individual participant dataSharing planned: No. Deidentiifed data including specific IgE, results of basophil assay and what individual food that the patient is reacting to will be included.
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan M Spergel, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy and Eosinophilic Esophagitis, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sample for mechanistic studies: (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832324, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.