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

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ClinicalTrials.gov Identifier: NCT02192866
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : June 28, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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 and Massachusetts General Hospital 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, and The Children's Hospital 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.

Condition or disease
Peanut Allergies Tree Nut Allergies Other Food Allergies

Study Design
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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies
Actual Study Start Date : February 2014
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Peanut allergic
No intervention(s) to be administered.
Other food allergic
No intervention(s) to be administered.
Controls
No intervention(s) to be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Identify which traits are associated with severe food allergy. [ Time Frame: 1 day of single blood draw ]
    This is an observational study, to describe traits (identified through blood tests) associated with severe food allergy, particularly peanut allergy.


Biospecimen Retention:   Samples With DNA
Blood samples.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

    • 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.

    • 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.

    • Inclusion criteria:

      1. excellent history of a systemic reaction to peanuts,
      2. age 6-75.

  4. Patients with other food allergies (especially tree nuts).

    • Inclusion criteria:

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

  5. Normal controls.

    • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192866


Contacts
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Contact: Stephen Dreskin, MD, PhD 303-724-7190 Stephen.Dreskin@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Spodra Eglite    303-724-7193    Spodra.Eglite@ucdenver.edu   
Principal Investigator: Stephen C Dreskin, MD, PhD         
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Stephen Dreskin, MD, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02192866    
Other Study ID Numbers: 13-2102
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Peanut Hypersensitivity
Nut Hypersensitivity
 Immune System Diseases
Hypersensitivity, Immediate
Nut and Peanut Hypersensitivity