|
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00329784 |
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.
Condition | Intervention |
Peanut Hypersensitivity Eczema Egg Hypersensitivity Food Hypersensitivity |
Dietary Supplement: Age appropriate peanut snack Behavioral: Peanut avoidance |
MedlinePlus related topics: | Allergy Eczema Food Allergy |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children |
Estimated Enrollment: | 640 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | November 2014 |
Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Peanut Consumption Group
|
Dietary Supplement: Age appropriate peanut snack
children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
|
2: Active Comparator
Peanut Avoidance Group
|
Behavioral: Peanut avoidance
avoidance of peanut as per 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 frist 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 realtively 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 consuption 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 dieticians.
Ages Eligible for Study: | 4 Months to 10 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Study Contact | 0800 234 6522 | info@leapstudy.co.uk |
United Kingdom, England | |||||
Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust | Recruiting | ||||
London, England, United Kingdom, SE1 7EH | |||||
Contact: Study Information 0800 234 6522 info@leapstudy.co.uk | |||||
Principal Investigator: Gideon Lack, MD |
National Institute of Allergy and Infectious Diseases (NIAID) |
Immune Tolerance Network |
Principal Investigator: | Gideon Lack, MD | Imperial College, St. Mary's Hospital |
LEAP Study informational website 
  |
Immune Tolerance Network website 
  |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN032AD |
First Received: | May 23, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00329784 |
Health Authority: | United States: Federal Government; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
|
|
|
|
|