An observational study in Peanut Allergies, Tree Nut Allergies and Other Food Allergies, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 1 Year to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-19.
Sponsored by University of Colorado, Denver · Observational
Food allergies are now a major problem. These experiments involve getting blood from people with food allergies and from people without food allergies. The blood collected will be used to answer questions and find information about peanut and other food allergies.
Samples will come from:
Blood and health histories from the University of North Carolina, Massachusetts General Hospital, National Jewish Health, The Children's Hospital and the Immune Tolerance Network will not have personal information linked.
The specific aims of this experiment are:
Overview: This is a protocol for obtaining serum, plasma, and cells from subjects with specific food allergies and from controls to be used in studies of peanut and other allergens. We are only asking the CTRC for help with drawing blood, separating serum, labeling tubes and to aliquot the serum. In addition, we will receive de-identified serum and plasma from other institutions and de-identified cord blood from the University of Colorado Denver Cord Blood bank.
The previous version of this application was COMIRB protocol 09-0813. This was last updated 03-03-2016. Much of the work outlined in protocol 09-0813 was completed and a manuscript is under review. This protocol is still only for the purpose of drawing blood and obtaining clinical histories. As such the risks and benefits in the informed consent have not changed.
Based on new NIH funding (RO3 AI 164349; started 7-09-21) and RO1-AI165866 (9th %-tile; scheduled to begin 09-01-21), the project now includes 5 specific aims (Aims #1-5). Aims 1 \& 2 are part of an R21 funded project (R21 AI135397; 11/16/2018-10/31/2020; extended until 10/31/2021 without additional funds) to Dr. Dreskin. Aims 3 \& 4 are part of an R21 funded project (R21 AI137881; 11/28/2018-10/31/2020; extended until 10/31/2021 without additional funds) to Dr. Chen (Dr. Dreskin is Co-PI). These proposals are highly complementary and each only needs access to blood samples. Dr. Dreskin's proposal consists of in vitro experiments to test IgE binding to novel peptides. Dr. Chen's proposal uses human serum or plasma as a source of IgE with which to identify and characterize mimotopes for murine studies. Aim 5 is an exploratory aim to obtain preliminary data for an RO1 to be submitted in 2019. For all of these projects, the only experiments that involve human materials are ex vivo assays of basophil activation, in vitro assays of IgE binding and generation of humanized mice using de-identified cord blood that will otherwise be discarded. There are no therapeutic interventions for human subjects.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 270 is above the median of 220 across 30 observational studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults and children who are allergic to peanuts and/or tree-nuts and individuals with no known food allergies.
Inclusion Criteria:
This protocol is to draw blood for a variety of related studies of food allergy. For this reason, we will list each group of subjects and the inclusion criteria for that group.
De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT) for peanut allergy. These samples already exist.
Inclusion criteria:
De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.
Inclusion criteria:
Patients with peanut allergy.
Inclusion criteria:
Patients with other food allergies (especially tree nuts).
Inclusion criteria:
Normal controls.
Inclusion criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention(s) to be administered.
No intervention(s) to be administered.
No intervention(s) to be administered.
Identify which traits are associated with severe food allergy.
This is an observational study, to describe traits (identified through blood tests) associated with severe food allergy, particularly peanut allergy.
Time frame: 1 day of single blood draw
Plan to share: No
Started Feb 2014 (actual). Primary completion is estimated for Dec 2030, 202 months after the start.
How these figures are worked out, and which studies are left out of them.
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