Collecting blood samples to study food allergies
Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies
University of Colorado, Denver · NCT02192866
This study is collecting blood samples from people with food allergies and healthy individuals to learn more about how food allergies work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 1 Year to 75 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Drugs / interventions | omalizumab, ImmunoTherapy |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT02192866 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood samples from individuals with peanut, tree nut, and other food allergies, as well as from healthy controls. The samples will be used to investigate the underlying mechanisms of food allergies and to enhance understanding of peanut and other allergens. Blood will be drawn and processed at various collaborating institutions, including the University of Colorado Denver and Massachusetts General Hospital. The study will also utilize de-identified serum and plasma from other sources to support its research objectives.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 1-75 with a history of peanut or tree nut allergies, or those undergoing oral food challenges.
Not a fit: Patients without food allergies or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of food allergies, potentially benefiting patients through better diagnostic and treatment options.
How similar studies have performed: Other studies have shown success in using blood samples to investigate food allergies, making this approach both relevant and promising.
Eligibility criteria
Show full 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.
* 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
Where this trial is running
Denver, Colorado
- University of Colorado School of Medicine — Denver, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Stephen Dreskin, MD, PhD — University of Colorado, Denver
- Study coordinator: Stephen Dreskin, MD, PhD
- Email: Stephen.Dreskin@ucdenver.edu
- Phone: 303-724-7190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peanut Allergies, Tree Nut Allergies, Other Food Allergies