Mucosal Immunotherapy for Peanut Allergy (MIT)
The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Mucosal Immunotherapy for Peanut Allergy|
- An outcome measure will be determined by a comparison of the result of the double blind placebo controlled food challenges (DBPCFC)at the starting point and at the end of the study for each of the subjects. [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
- Other outcome measures will be the changes seen in the pre and post peanut skin tests and the pre and post IgE levels to peanut [ Time Frame: Three years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Oat flour
This subject receives oat flour from the beginning as the placebo until the unblinding food challenge.
Active Comparator: Peanut flour
The subjects who receive peanut flour as mucosal immunotherapy at the start and throughout the study
Biological: Peanut flour
Defatted peanut flour to be administered
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut mucosal immunotherapy (MIT). We are also studying the effect of peanut MIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six with peanut allergy will be randomized to peanut MIT or placebo. Subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut MIT using appropriate statistical analysis.
|United States, Arkansas|
|University of Arkansas Medical Center|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Arvil W Burks, MD||University of North Carolina, Chapel Hill|