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

This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), July 2008

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
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Proportion of participants with peanut allergy at 60 months of age [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

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.

  Eligibility
Ages Eligible for Study:   4 Months to 10 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329784

Contacts
Contact: Study Contact     0800 234 6522     info@leapstudy.co.uk    

Locations
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            

Sponsors and Collaborators

Investigators
Principal Investigator:     Gideon Lack, MD     Imperial College, St. Mary's Hospital    
  More Information


LEAP Study informational website  This link exits the ClinicalTrials.gov site
 
Immune Tolerance Network website  This link exits the ClinicalTrials.gov site
 

Publications:

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
peanut allergy  
egg allergy  
eczema  
peanut  
allergy  
allergies
allergic reaction
anaphylaxis
infants
children

Study placed in the following topic categories:
Hypersensitivity
Food Hypersensitivity
Skin Diseases
Anaphylaxis
Peanut Hypersensitivity
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Eczema
Egg Hypersensitivity
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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