This trial is active, not recruiting.

Condition peanut hypersensitivity
Treatments peanut, oat flour
Phase phase 2
Sponsor University of North Carolina, Chapel Hill
Start date April 2009
End date June 2016
Trial size 60 participants
Trial identifier NCT00815035, 11-2315


Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).

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
(Active Comparator)
These subjects will be randomized to receive the active peanut protein flour.
peanut Peanut OIT
Peanut flour will be given in increasing amounts.
(Placebo Comparator)
These subjects will be randomized to receive oat flour.
oat flour Placebo
The doses of oat flour will be increases every 2 weeks until a maintenance dose is achieved.
(No Intervention)
Subjects will be enrolled who meet the inclusion/exclusion criteria and followed as matched controls. These subjects will not receive any treatment.

Primary Outcomes

To treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance.
time frame: 4 years

Secondary Outcomes

To determine the molecular-level effect that peanut OIT has on the peanut-specific cellular and humoral activity/response in peanut-allergic subjects.
time frame: 4 years

Eligibility Criteria

Male or female participants from 1 year up to 6 years old.

Inclusion Criteria: - Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit - The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L - A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts - Provide signed informed consent Exclusion Criteria: - History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence) - Currently participating in a study using an investigational new drug - Participation in any interventional study for the treatment of food allergy in the past 12 months - Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat - Poor control or persistent activation of atopic dermatitis - Moderate to severe persistent asthma - Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines - Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs)

Additional Information

Official title Oral Immunotherapy for Peanut Allergy- Peanut Oral Immunotherapy (PnOIT3)
Principal investigator Wesley 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 oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active 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 OIT using appropriate statistical analysis.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.