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Promoting Tolerance to Peanut in High-Risk Children (LEAP)

This study is currently recruiting participants.
Study NCT00329784.   Last updated on September 26, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  Promoting Tolerance to Peanut in High-Risk Children
Official Title  Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children
Brief Summary

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.

Detailed Description

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.

Study Phase
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Proportion of participants with peanut allergy at 60 months of age [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Effect of peanut consumption or avoidance on other allergy outcomes [ Time Frame: 30 and 60 months ] [ Designated as safety issue: Yes ]
safety of peanut consumption among study participants [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
immunologic mechanisms by which consumption of a peanut-containing snack may induce tolerance to peanuts [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Condition  Peanut Hypersensitivity
Eczema
Egg Hypersensitivity
Food Hypersensitivity
Intervention  Dietary Supplement: Age appropriate peanut snack
Behavioral: Peanut avoidance
MEDLINE PMIDs 15536431,   16670515
Links LEAP Study informational website This link exits the ClinicalTrials.gov site
Immune Tolerance Network website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  640
Start Date  December 2006
Completion Date November 2014
Eligibility Criteria 

Inclusion Criteria:

  • Allergy to eggs and/or severe eczema
  • Live within traveling distance to London, England, United Kingdom

Exclusion Criteria:

  • Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
  • Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
  • Previous or current consumption of peanut
  • Previous allergic reaction to peanut
  • Has sibling or primary caregiver who is allergic to peanut
  • Certain other immunologic criteria
Gender Both
Ages 4 Months to 10 Months
Accepts Healthy Volunteers No
Contacts ††
Contact: Study Contact     0800 234 6522     info@leapstudy.co.uk    
Location Countries  United Kingdom
Administrative Information Fields
NCT ID  NCT00329784
Organization ID ITN032AD
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators †† Immune Tolerance Network
Investigators 
Principal Investigator:     Gideon Lack, MD     Imperial College, St. Mary's Hospital    
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date July 2008
First Received Date  May 23, 2006
Last Updated Date September 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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