Promoting Tolerance to Peanut in High-Risk Children (LEAP)
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).
Biological: Peanut Consumption Group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children (ITN032AD)|
- Proportion of Participants with Peanut Allergy at 60 Months of Age [ Time Frame: 60 months ] [ Designated as safety issue: No ]Method of determination: oral food challenge
- Proportion of Participants with Allergic Sensitization to Selected Ingested and Inhaled Allergens, and with Seasonal Rhinoconjunctivitis, Perennial Rhinoconjunctivitis, and Asthma [ Time Frame: 30 and 60 months ] [ Designated as safety issue: No ]
- Proportion of Participants with Type-1 Immediate Onset Food Allergy to Selected Ingested Allergens [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
- Incidence of Adverse Events (AEs), Laboratory Abnormalities and Nutritional Evaluations [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Peanut Consumption Group
Participants on this arm will consume peanut protein.
Biological: Peanut Consumption Group
Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
Other Name: Bamba
No Intervention: Peanut Avoidance Group
Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329784
|Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust|
|London, England, United Kingdom, SE1 7EH|
|Principal Investigator:||Gideon Lack, MD||Imperial College, St. Mary's Hospital|