Participating in the LEAP Study

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PLEASE NOTE THAT THAT LEAP STUDY IS NOW FULL.
WE ARE NO LONGER ACCEPTING CHILDREN INTO THE STUDY.
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Participants in the LEAP study have been randomly assigned to one of two groups.

Children in the "consumption group", are asked to feed their child a peanut-based snack 3 times per week. Those assigned to the "avoidance group", are asked to help their child follow a diet that completely excludes peanut-containing foods up until the age of 3.

The study lasts a total of approximately 5 years. During this time, participants receive:

Nutrition/Allergy Counselling

In order to help participants meet the requirements of their assigned study group, they receive regular dietary consultations by phone with the study's registered dietitians or nurses. Phone consultations take place weekly in the first year, tapering to once a month for the final 2 years. Our staff are also available to answer specific questions or provide advice as needed by participants. Participating families will also receive written tips, advice and guidelines to help maintain a healthy diet while adhering to the study requirements.

Study nurses, dietitians and doctors are available during the course of the study to answer questions and provide advice on childhood allergy prevention and treatment. If, at any time during the study, your child is diagnosed with peanut allergy or any other allergies, study specialists will provide you with appropriate advice about living with and treating childhood allergies. We will continue to monitor you in the appropriate clinic for as long as necessary.

Study Visits

Parents in both study groups will be asked to bring their children into Evelina Children's Hospital to meet with the study specialists on five (5) separate occasions during the study. Study staff will attempt to be flexible such that study visits take place at mutually convenient times. Any transport or parking costs will be covered by the study.

If your child is assigned to the consumption group, medical supervision will be provided at St Thomas’ Hospital during your child's first exposure to peanut.

Study Procedures

Participating children will be asked to consent to the following procedures during study visits:

Medical/Dietary/Family history: Study specialists will interview parents to develop a history of your child's medical condition, dietary consumption and family history of allergic diseases.

Physical Examination: A physical examination of your child by study specialists will take place at each study visit.

Allergy testing: A skin prick test will be performed to determine whether your child is allergic to peanut and/or other common allergens, during screening (prior to enrolment) and during study visits.

Blood sample: Blood samples will be drawn during study visits for routine medical assessments and to perform laboratory testing of immune cells.

Please note that participation in this and any clinical trial is strictly voluntary. If you are considering participating in this study, we recommend that you consult the resources linked on the right for information on your rights as a clinical trial participant.

Find out if your child is eligible to participate ...

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