NCT02192866 · University of Colorado, Denver
Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- patients have been enrolled in a controlled trial of OIT for peanuts, and had at least one oral challenge.
- De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.
- concern regarding possible allergy to peanuts,
- plan to undergo a clinically indicated challenge with peanuts.
- Patients with peanut allergy.
- excellent history of a systemic reaction to peanuts,
- Patients with other food allergies (especially tree nuts).
- excellent history of a systemic reaction to tree nuts or other foods,
- Normal controls.
- no known food allergies,
- recent ingestion of peanuts without difficulty, and
Exclusion criteria
- Any known significant medical or psychiatric diagnosis
- Use of an investigational drug within 30 days
- Use of omalizumab (anti-IgE; Xolair) within 6 months
Where
- Denver, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2022 · Source of record for eligibility and locations