Sublingual Immunotherapy for Peanut Allergy and Induction of Tolerance
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Jun 13, 2011
Trial Information
Current as of June 20, 2025
Completed
Keywords
ClinConnect Summary
Allergy to peanuts and tree nuts affects approximately 1.4% of the population. Allergic reactions to peanut can be severe and life threatening and account for the vast majority of fatalities due to food-induced anaphylaxis. At present, there are no viable treatment options for patients with peanut allergy. The current standard of care is strict dietary elimination and emergency preparedness with an anaphylaxis kit in the event of an accidental reaction.
Our group and others have shown that oral immunotherapy can provide protection from anaphylaxis to a variety of food proteins. In addition...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Between ages 1 year to 12 years exclusive
- • Peanut specific IgE \> 0.35kU/L or a convincing clinical history of an allergic reaction to peanut within 1 hour of ingestion
- • Positive entry DBPCFC to 1 gram of peanut protein
- Exclusion Criteria:
- • History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
- • 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 National Heart Lung and Blood Institute (NHLBI) guidelines 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
About University Of North Carolina, Chapel Hill
The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chapel Hill, North Carolina, United States
Patients applied
Trial Officials
Wesley Burks, MD
Principal Investigator
University of North Carolina
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials