Oral Immunotherapy for Peanut Allergy (PMIT)

University of North Carolina (UNC)

Status and phase

Completed

Phase 2

Conditions

Food Hypersensitivity

Treatments

Biological: Placebo

Biological: Peanut OIT

Study type

Interventional

Funder types

Other

Identifiers

NCT00597675

Pro00000163

Details and patient eligibility

About

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.

Full 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 mucosal 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 1 to 18 with peanut allergy will be randomized to peanut OIT 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. Subjects will undergo a double-blind, placebo-controlled food challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects will then complete at least 36 months of peanut OIT therapy after which once skin prick (<5 mm) and IgE (<15 kU/L) criteria are met, they will then complete the end of study DBPCFC. Dosing will continue up to a maximum of 60 months after which even if criteria are not met, the subject will undergo the end of study DBPCFC. Outcome variables of interest include response to DBPCFC, 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.

Enrollment

10 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject between 1 and 18 years of age
EITHER history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts greater than 6 months ago AND peanut specific IgE >15 kU/L
OR history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts within the past 6 months AND peanut specific IgE > 7 kU/L
A family that will be able to be compliant with all study visits
All females of child bearing age must be using appropriate birth control

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
Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
Diagnosed oat allergy
Pregnancy or lactation