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

NCT02192866 | Recruiting DMC

• 2 other identifiers: 13-2102UL1TR001082
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peanut Allergies; Tree Nut Allergies; Other Food Allergies

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day of single blood draw

Study Arms (3)

Peanut allergic

No intervention(s) to be administered.

Other food allergic

No intervention(s) to be administered.

Controls

No intervention(s) to be administered.

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults and children who are allergic to peanuts and/or tree-nuts and individuals with no known food allergies.

You may qualify if:

• De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT) for peanut allergy. These samples already exist.
• patients have been enrolled in a controlled trial of OIT for peanuts, and had at least one oral challenge.
• Age 1-75.
• De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.
• concern regarding possible allergy to peanuts,
• age 1-75,
• plan to undergo a clinically indicated challenge with peanuts.
• Patients with peanut allergy.
• excellent history of a systemic reaction to peanuts,
• age 6-75.
• Patients with other food allergies (especially tree nuts).
• excellent history of a systemic reaction to tree nuts or other foods,
• age 6-75.
• Normal controls.
• no known food allergies,

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Colorado School of Medicine

Denver, Colorado, 80045, United States

RECRUITING

Related Publications (4)

• Dreskin SC, Koppelman SJ, Andorf S, Nadeau KC, Kalra A, Braun W, Negi SS, Chen X, Schein CH. The importance of the 2S albumins for allergenicity and cross-reactivity of peanuts, tree nuts, and sesame seeds. J Allergy Clin Immunol. 2021 Apr;147(4):1154-1163. doi: 10.1016/j.jaci.2020.11.004. Epub 2020 Nov 18.

  PMID: 33217410 RESULT

• Hazebrouck S, Patil SU, Guillon B, Lahood N, Dreskin SC, Adel-Patient K, Bernard H. Immunodominant conformational and linear IgE epitopes lie in a single segment of Ara h 2. J Allergy Clin Immunol. 2022 Jul;150(1):131-139. doi: 10.1016/j.jaci.2021.12.796. Epub 2022 Feb 10.

  PMID: 35150723 RESULT

• Hazebrouck S, Canon N, Dreskin SC. The Effector Function of Allergens. Front Allergy. 2022 Feb 7;3:818732. doi: 10.3389/falgy.2022.818732. eCollection 2022.

  PMID: 35386644 RESULT

• Dreskin SC, Germinaro M, Reinhold D, Chen X, Vickery BP, Kulis M, Burks AW, Negi SS, Braun W, Chambliss JM, Eglite S, McNulty CMG. IgE binding to linear epitopes of Ara h 2 in peanut allergic preschool children undergoing oral Immunotherapy. Pediatr Allergy Immunol. 2019 Dec;30(8):817-823. doi: 10.1111/pai.13117. Epub 2019 Oct 21.

  PMID: 31437325 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Peanut Hypersensitivity; Nut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Stephen Dreskin, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Dreskin, MD, PhD

CONTACT

303-724-7190; Stephen.Dreskin@ucdenver.edu

Study Design

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

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: July 17, 2014
• Study Start: February 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)