Peanut Oral Immunotherapy (Peanut OIT)
This is a study in which increasing amounts of peanut flour are given to the children who are peanut allergic to desensitize them to peanut. The hypothesis is that the peanut allergic patients would benefit from the desensitization by assuring that they will not have life-threatening allergic reactions to contaminating amounts of peanut in other foods and eventually it would cause them to lose their clinical sensitivity to peanut.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oral Peanut Immunotherapy for Peanut Allergic Patients|
- Subject will pass a double blind placebo food challenge (DBPCFC) at the end of the study and a second food challenge 1 month later after being off of peanut for 1 month. [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
- IgE to peanut will decrease below a level of 2 [ Time Frame: End of the study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Peanut flour
Subjects, who are peanut allergic, are given peanut flour for desensitization with the hypothesis that they will develop tolerance to peanut.
Drug: Peanut flour
Defatted Peanut Flour
Peanut allergy is one of the most serious of the immediate hypersensitivity reactions to foods in terms of persistence and severity of the reaction and appears to be a growing problem. Due to the persistence of this reaction and the lack of effective treatment, allergen-specific immunotherapy (IT)using the oral route of ingestion is currently being examined as a treatment option. An understanding of the molecular mechanisms of peanut-specific IT is vital to ensure the eventual, successful treatment of peanut-allergic patients.
This study will examine not only the child's response to the oral peanut flour but will also examine the changes in the immunological system which is responsible for the peanut allergy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598039
|United States, Arkansas|
|University of Arkansas|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Wesley Burks, MD||University of North Carolina, Chapel Hill|