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

This study has been completed.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00329784
First received: May 23, 2006
Last updated: January 25, 2017
Last verified: January 2017
Results First Received: November 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Eczema
Egg Allergy
Food Allergy
Intervention: Biological: Peanut Consumption Group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants between 4 and 11 months of age with pre-existing allergy to egg and/or severe eczema were recruited in the United Kingdom between December 2006 and May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified into cohorts based on a skin prick test for peanut allergen. Participants were either negative (no measureable wheal after test) or positive (a wheal measuring between 1 and 4 mm in diameter). Participants were then randomized into treatment groups.

Reporting Groups
  Description
Negative Stratum - Peanut Avoidance Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
Negative Stratum - Peanut Consumption Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.

Participant Flow:   Overall Study
    Negative Stratum - Peanut Avoidance Group   Negative Stratum - Peanut Consumption Group   Positive Stratum - Peanut Avoidance Group   Positive Stratum - Peanut Consumption Group
STARTED   270   272   51   47 
COMPLETED   265   267   51   47 
NOT COMPLETED   5   5   0   0 
Lost to Follow-up                0                1                0                0 
Withdrawal by Subject                4                2                0                0 
Unspecified                1                2                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat

Reporting Groups
  Description
Negative Stratum - Peanut Avoidance Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
Negative Stratum - Peanut Consumption Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Total Total of all reporting groups

Baseline Measures
   Negative Stratum - Peanut Avoidance Group   Negative Stratum - Peanut Consumption Group   Positive Stratum - Peanut Avoidance Group   Positive Stratum - Peanut Consumption Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 270   272   51   47   640 
Age 
[Units: Months]
Mean (Standard Deviation)
 7.7  (1.7)   7.7  (1.8)   8.4  (1.7)   7.9  (1.6)   7.8  (1.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      96  35.6%      124  45.6%      17  33.3%      19  40.4%      256  40.0% 
Male      174  64.4%      148  54.4%      34  66.7%      28  59.6%      384  60.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United Kingdom   270   272   51   47   640 
Severe Eczema [1] 
[Units: Participants]
Count of Participants
 236   246   48   41   571 
[1] Number of participants with severe eczema at baseline. Eczema is any type of dermatitis or inflammation of the skin. Severe eczema for this trial is based on three criteria. The first criterion was the parent or guardians’ description of their child’s eczema severity. The second criterion was the use of topical creams or ointments containing corticosteroids or calcineurin inhibitors. The third criterion will be a modified Scoring Atopic Dermatitis System (SCORAD). Infants with severe eczema are at a high risk of developing a peanut allergy
Age at Onset of Eczema [1] 
[Units: Months]
Mean (Standard Deviation)
 2.2  (1.7)   2.3  (1.6)   2.1  (1.6)   2.4  (1.5)   2.3  (1.6) 
[1] Age in months at which eczema symptoms began. Eczema is any type of dermatitis or inflammation of the skin. Severe eczema for this trial is based on three criteria. The first criterion was the parent or guardians’ description of their child’s eczema severity. The second criterion was the use of topical creams or ointments containing corticosteroids or calcineurin inhibitors. The third criterion will be a modified Scoring Atopic Dermatitis System (SCORAD). Infants with severe eczema are at a high risk of developing a peanut allergy
SCORAD [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 35.0  (19.9)   33.3  (18.4)   33.7  (16.2)   37.8  (18.6)   34.4  (18.9) 
[1] A modified Scoring Atopic Dermatitis System (SCORAD) was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child’s eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. Scores less than 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Total IgE [1] 
[Units: kUA/L]
Mean (Standard Deviation)
 95.1  (321.8)   76.4  (181.4)   125.7  (174.8)   306.4  (666.5)   104.8  (307.9) 
[1] Total Immunoglobulin E (IgE) includes the following potential allergens: peanut, hen’s egg white, cow’s milk, sesame, brazil nut, hazel nut, cashew, almond, walnut, house dust mite, cat dander, dog dander, timothy grass pollen, alternaria mold, and birch tree pollen. IgE is measured in a serum sample. Results <75 kUA/L suggests that the participant is not allergic to any of the potential allergens. A result >75 kUA/L suggests at least a mild clinical allergy. The higher the total IgE present in the serum sample, the more likely it is to be a presence of an allergy to at least one allergen
Peanut-specific IgE [1] 
[Units: kUA/L]
Median (Inter-Quartile Range)
 0.0 
 (0.0 to 0.2) 
 0.0 
 (0.0 to 0.1) 
 0.4 
 (0.1 to 3.0) 
 1.3 
 (0.2 to 5.5) 
 0.0 
 (0.0 to 0.3) 
[1] Immunoglobulin E (IgE) is an antibody produced by the immune system. If you have an allergy, your immune system overreacts to an allergen by producing antibodies called IgE. These antibodies travel to cells that release chemicals, causing an allergic reaction. Peanut-specific IgE is measured in a serum sample following a peanut skin prick test. Results <0.35 kUA/L is considered low level allergic reaction to peanut. Results from >= 0.35 to <15 kUA/L are considered mid-level allergic reaction to peanut. Results >=15 kUA/L are considered high level allergic reaction to peanut.


  Outcome Measures
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1.  Primary:   Number of Participants With Peanut Allergy at 60 Months of Age – by Skin Prick Test Stratum   [ Time Frame: 60 months ]

2.  Primary:   Number of Participants With Peanut Allergy at 60 Months of Age – Both Strata Combined   [ Time Frame: 60 months ]

3.  Secondary:   SCORAD at 60 Months   [ Time Frame: 60 months ]

4.  Secondary:   Number of Participants With Asthma at 60 Months   [ Time Frame: 60 months ]

5.  Secondary:   Number of Participants With Rhinitis at 60 Months   [ Time Frame: 60 months ]

6.  Secondary:   Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm   [ Time Frame: 60 months ]

7.  Secondary:   Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L   [ Time Frame: 60 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00329784     History of Changes
Other Study ID Numbers: DAIT ITN032AD
Study First Received: May 23, 2006
Results First Received: November 1, 2016
Last Updated: January 25, 2017