Sublingual Immunotherapy for Peanut Allergy and Induction of Tolerance
Completed · Phase 1/Phase 2
Conditions studied: Peanut Hypersensitivity, Food Hypersensitivity, Food Allergy, Peanut Allergy
In brief
The goal of this study will be to increase the reaction threshold (desensitization) of peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance).
Key facts
- Study ID
- NCT01373242
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 54
- Starts
- 2011-06-01
- Expected to finish
- 2018-04-16
- Last updated by the study team
- 2019-06-12
Who can join
Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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