Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies

Study Purpose

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:

- People signed up by the investigators at the University of Colorado Denver.

- University of North Carolina, Massachusetts General Hospital, Children's Hospital of Colorado and the Immune Tolerance Network (Benaroya Research Institute) where people have been treated for peanut allergies.

- University of North Carolina, Massachusetts General Hospital, National Jewish Health and The Children's Hospital in Denver where people have taken part or will take part in clinically indicated oral food challenges.

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: 1. Come up with a lab test that will predict how bad an allergic reaction will be to peanuts. 2. Find out what part of a peanut causes allergic reactions. 3. Come up with preventions that can block peanut allergies. 4. Find the strongest proteins in walnuts.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Year - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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. 1. De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT) for peanut allergy. These samples already exist.

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Inclusion criteria:
1.

patients have been enrolled in a controlled trial of OIT for peanuts, and had at least one oral challenge. 2. Age 1-75. 2. De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.

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Inclusion criteria:
1.

concern regarding possible allergy to peanuts, 2. age 1-75, 3. plan to undergo a clinically indicated challenge with peanuts. 3. Patients with peanut allergy.

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Inclusion criteria:
1.

excellent history of a systemic reaction to peanuts, 2. age 6-75. 4. Patients with other food allergies (especially tree nuts).

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Inclusion criteria:
1.

excellent history of a systemic reaction to tree nuts or other foods, 2. age 6-75. 5. Normal controls.

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Inclusion criteria:
1.

no known food allergies, 2. recent ingestion of peanuts without difficulty, and. 3. age 6-75.

Exclusion Criteria:

1. Any known significant medical or psychiatric diagnosis. 2. Use of an investigational drug within 30 days. 3. Use of omalizumab (anti-IgE; Xolair) within 6 months

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02192866
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stephen Dreskin, MD, PhD
Principal Investigator Affiliation	University of Colorado, Denver
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergies, Tree Nut Allergies, Other Food Allergies

Additional Details

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.

Arms & Interventions

Arms

: Peanut allergic

No intervention(s) to be administered.

: Other food allergic

No intervention(s) to be administered.

: Controls

No intervention(s) to be administered.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Denver, Colorado

Status

Recruiting

Address

University of Colorado School of Medicine

Denver, Colorado, 80045

Site Contact

Stephen C Dreskin

stephen.dreskin@cuanschutz.edu

303-877-2754

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