Recruiting

Food Allergies

Sponsor:

University of Colorado, Denver

Code:

NCT02192866

Conditions

Peanut Allergies

Tree Nut Allergies

Other Food Allergies

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

Study Details

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:

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.

Conditions

Peanut Allergies

Tree Nut Allergies

Other Food Allergies

Study ID

NCT02192866

Start date

Feb, 2014

Status verified date

Dec, 2022

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

270 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • Identify which traits are associated with severe food allergy. [ Time Frame: 1 day of single blood draw ]

Central Contacts and Locations

Central contacts

Stephen Dreskin, MD, PhD

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

Locations

University of Colorado School of Medicine

Recruiting

Denver, Colorado, United States, 80045

Contacts

Stephen C Dreskin

303-877-2754stephen.dreskin@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Dec 19, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2022-12-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.