Immunotherapy for Peanut Allergy
NCT00429429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2016-06-20
Summary
Currently, when a food allergy is diagnosed, the "standard of care" is strict avoidance of the allergic food and ready access to self-injectable epinephrine. Yet, accidental ingestions do occur. Unfortunately, for a ubiquitous food such as peanut, the possibility of an inadvertent ingestion is great. It is estimated that over 50% of individuals who are allergic to peanuts will have an accidental reaction to peanuts over a 2-year period. The purpose of this study is to determine if peanut sublingual immunotherapy (SLIT) reduces the number and/or symptoms of accidental peanut ingestion in peanut allergic subjects. We would anticipate that the subjects on the peanut SLIT protocol would experience few adverse effects with accidental peanut ingestion over the course of the two years of SLIT. The primary endpoint to evaluate the effectiveness of SLIT will be a negative DBPCFC to peanuts (8 grams) at the completion of the two years of the study.
Conditions
- Allergy
Interventions
- PROCEDURE
-
Sublingual immunotherapy
Drops of peanut protein placed and held under the tongue for a specific time before swallowed.
Sponsors & Collaborators
-
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Wesley Burks, MD · University of North Carolina
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2011-05-31
- Completion
- 2011-05-31
Countries
- United States
Study Locations
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