About the LEAP Study
The LEAP Study is a clinical research study that aims to determine the best strategy to prevent peanut allergy in young children. Two approaches will be tested in the study - the avoidance of peanut in infancy (as per current Department of Health guidelines) and the measured, repeated consumption of peanut-containing foods in infancy.
The majority of children have their first allergic reaction to peanut between 14 and 24 months of age. Children suffering from eczema or who are allergic to egg are at highest risk - these children have a 20% chance of going on to develop a peanut allergy.
The LEAP Study involves 640 such high-risk children who were enrolled in the study when aged 4-10 months. Each child was randomly assigned to follow one of the two approaches – avoidance or consumption. Children in the avoidance group avoid eating peanut-containing foods until they reach the age of three. In the consumption group, parents are asked to feed their child an age-appropriate peanut snack three times per week (equivalent to about 6 grams of peanut protein per week). All participants receive allergy testing, dietary counselling, physical examinations and will be asked to provide occasional blood samples that will be used to examine differences in immune system development in each of the study groups.
The proportion of each group that develops peanut allergy by 5 years of age will be used to determine which approach - avoidance or consumption - works best for preventing peanut allergy.
We anticipate that the study will reach completion in 2013, at which time the results will be analysed and published.
The LEAP Study has ethical approval from the St Mary’s Research Ethics Committee (Reference: 04/Q0403/13) and local research and development approval from Guy’s and St Thomas’ NHS Foundation Trust (RJ1 06/0277). The Immune Tolerance Network, along with the NIAID and the NIAID Data and Safety Monitoring Board, an independent review board in the US, have also reviewed the study protocol to ensure it meets high levels of safety and ethical standards.