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

This study has been completed.
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: May 23, 2006
Last updated: August 30, 2016
Last verified: August 2016

May 23, 2006
August 30, 2016
December 2006
May 2014   (final data collection date for primary outcome measure)
Proportion of Participants with Peanut Allergy at 60 Months of Age [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Method of determination: oral food challenge
Proportion of children developing peanut allergy by age 5 in the peanut and avoidance groups
Complete list of historical versions of study NCT00329784 on Archive Site
  • Proportion of Participants with Allergic Sensitization to Selected Ingested and Inhaled Allergens, and with Seasonal Rhinoconjunctivitis, Perennial Rhinoconjunctivitis, and Asthma [ Time Frame: 30 and 60 months ] [ Designated as safety issue: No ]
  • Proportion of Participants with Type-1 Immediate Onset Food Allergy to Selected Ingested Allergens [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • Incidence of Adverse Events (AEs), Laboratory Abnormalities and Nutritional Evaluations [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • Effect of peanut consumption on other allergy outcomes
  • safety of peanut consumption among study participants
  • immunologic mechanisms by which consumption of a peanut-containing snack may induce tolerance to peanuts
Not Provided
Not Provided
Promoting Tolerance to Peanut in High-Risk Children
Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children (ITN032AD)

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.

This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).

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 first 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 relatively 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 consumption 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 dietitians.

Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Eczema
  • Egg Allergy
  • Food Allergy
Biological: Peanut Consumption Group
Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
Other Name: Bamba
  • Experimental: Peanut Consumption Group
    Participants on this arm will consume peanut protein.
    Intervention: Biological: Peanut Consumption Group
  • No Intervention: Peanut Avoidance Group
    Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able to consume solid food
  • Allergy to eggs and/or severe eczema
  • Informed consent obtained from parent or guardian.

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 protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
  • Investigator-suspected allergy to peanut protein
  • Investigator-suspected allergy to peanut protein in care provider or current household member.
  • Diagnosis of persistent asthma
  • ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
  • BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
  • Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
  • Unwillingness or inability to comply with study requirements and procedures
4 Months to 10 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
The plan is to share data in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available without charge.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Principal Investigator: Gideon Lack, MD Imperial College, St. Mary's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP