Status:
COMPLETED
FARE Peanut SLIT and Early Tolerance Induction
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Food Allergy Research & Education
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Peanut Hypersensitivity
Food Allergy
Eligibility:
All Genders
12-48 years
Phase:
PHASE2
Brief Summary
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a sta...
Detailed Description
Peanut allergy is one of the most common food allergies; most children develop this allergy early in life, do not outgrow it and are at risk for severe and life-ending anaphylactic reactions. There is...
Eligibility Criteria
Inclusion
- Written informed consent from participant's parent/guardian.
- Age 12-48 months of either sex, any race, any ethnicity.
- A peanut allergy diagnosis with a convincing clinical history of peanut allergy and a serum peanut-specific IgE \[UniCAP\] \> 0.35 kUA/L AND a positive skin prick test to peanut (\>3 mm than the negative control) OR are sensitized to peanut (based on a serum IgE \[UniCAP\] to peanut of \> 5 kUA/L) AND a positive skin prick test to peanut (\> 3 mm than the negative control) and no known history of ingestion of peanut.
- A positive DBPCFC to 1000 mg of peanut at enrollment.
Exclusion
- History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or peripheral capillary oxygen saturation (SpO2) \< 92% at any stage, hypotension, confusion, collapse or loss of consciousness).
- Participation in any interventional study for the treatment of food allergy in the past 6 months.
- Known oat, wheat, or glycerin allergy.
- Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease.
- Severe asthma (2007 NHLBI Criteria Steps 5 or 6 - Appendix 2).
- Inability to discontinue antihistamines for skin testing and DBPCFCs.
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year.
- Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers.
- Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02304991
Start Date
January 1 2015
End Date
December 31 2020
Last Update
January 10 2022
Active Locations (2)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235