This trial is active, not recruiting.

Condition food hypersensitivity
Treatments peanut flour, oat
Sponsor University of North Carolina, Chapel Hill
Collaborator University of Arkansas
Start date March 2007
End date December 2014
Trial size 45 participants
Trial identifier NCT00597675, Pro00000163


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Placebo Comparator)
This subject receives oat flour from the beginning as the placebo until the unblinding food challenge.
Oat flour
(Active Comparator)
The subjects who receive peanut flour as mucosal immunotherapy at the start and throughout the study
peanut flour
Defatted peanut flour to be administered

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 1 year up to 7 years old.

Inclusion Criteria: - Subject between 1 and 6 years of age - Diagnosed peanut allergy by immunoglobin E to peanut (IgE to peanut) greater than or equal to 15 within past 6 months and have eaten peanut in diet resulting in a clinical reaction prior to diagnosis - Diagnosed peanut allergy by immunoglobin E to peanut (IgE to peanut) greater than or equal to 7 within past 6 months and have had a clinical reaction to peanut ingestion within the past 6 months Exclusion Criteria: - Subjects with a history of severe, anaphylaxis to peanut - Medical history that would prevent a double blind placebo controlled oral food challenge (DBPCFC/OFC) to peanut

Additional Information

Official title Mucosal Immunotherapy for Peanut Allergy
Principal investigator Arvil W Burks, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.