Promoting Tolerance to Peanut in High-Risk Children (LEAP)

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 2

Conditions

Food Allergy

Eczema

Egg Allergy

Treatments

Biological: Peanut Consumption Group

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00329784

DAIT ITN032AD

Details and patient eligibility

About

This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema.

This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).

Full description

Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy.

Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts.

Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut.

Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians.

Enrollment

640 patients

Sex

All

Ages

4 to 10 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able to consume solid food
Allergy to eggs and/or severe eczema
Informed consent obtained from parent or guardian.

Exclusion criteria

Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
Investigator-suspected allergy to peanut protein
Investigator-suspected allergy to peanut protein in care provider or current household member.
Diagnosis of persistent asthma
ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
Unwillingness or inability to comply with study requirements and procedures