ITN032AD: 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. ITN049AD: This is a two-sample comparison employing all available study participants in both arms of the current LEAP study at V72. After obtaining informed consent LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into the LEAP-On Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B). At V72, after 12 months of this new intervention, all participants will have skinprick testing, specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms).

instance of dataset

2 - Complete set of descriptive data and results, as ascertained by ImmPort.

available with registration

ITN032AD: Primary Objective: Assess whether oral administration of a peanut-containing snack can induce tolerance in children at high risk for peanut allergy. Secondary: Assess the effect of peanut-containing snack on additional allergy outcomes. ITN049AD: Primary Objective: To evaluate persistent tolerance to peanut by assessing the effect of 12 months of cessation of peanut consumption after 5 years of consumption versus continued avoidance of peanut in the LEAP study population.

registration required

Peanut allergy

Gideon Lack

King's College London

principal investigator

LEAP ITN032AD: Induction of Tolerance through Early Introduction of Peanut in High-Risk Children, LEAP-On ITN049AD: The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis

640

Immune Tolerance Network

ITN032AD: Primary: Proportion of participants with peanut allergy at 60 months of age. Secondary: At 30 and 60 months of age, the proportion of participants with allergic sensitization to selected ingested and inhaled allergens, and with seasonal rhinoconjuncitivitis, perennial rhinoconjuncitivits, and asthma; proportion of participants with type-1 immediate onset food allergy to selected ingested allergens; incidence of adverse events, laboratory abnormalities and nutritional evaluations. ITN049AD: Primary: The primary endpoint is the proportion of participants with PA at V72 in Groups A and B. Comparison of the rate of peanut allergy between both groups at V72 will be made allowing for the evaluation of whether the early consumption of peanut induces a state of `persistent tolerance?. Secondary: The proportion of participants with peanut allergy at V60 and V72 in Group A only. The within group comparison in Group A between V72 and V60 will allow the identification and statistical evaluation of a group of children with `transient desensitisation?. The proportion of subjects with allergic sensitisation to selected ingested and inhaled allergens, and with seasonal rhino-conjunctivitis, perennial rhinoconjunctivitis, and asthma. Incidence of adverse events, and nutritional evaluations. Results of cellular and humoral assessments of immune response related to the development of allergy or tolerance to specific allergens.

Peanut Avoidance: Participants will avoid peanut consumption

Peanut Consumption: Participants will consume peanut protein

ITN032AD: 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. ITN049AD: This study will evaluate persistent tolerance to peanut by assessing the effect of 12 months of cessation of peanut consumption after 5 years of consumption versus continued avoidance of peanut.

10.21430/M3SFPACKA3

2006-12-01

ImmPort

SCR:012804