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Persistence of Oral Tolerance to Peanut (LEAP-On)

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:
NCT01366846
First received: June 2, 2011
Last updated: November 8, 2016
Last verified: November 2016
Results First Received: November 8, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Eczema
Egg Allergy
Food Allergy
Hypersensitivity
Intervention: Other: Avoidance of peanut

  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
From among those who completed the LEAP study (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), 556 subjects were recruited between 26 May 2011 and 6 June 2014 at Evelina Children’s Hospital in London, UK.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the LEAP trial, participants were stratified into strata based on a peanut allergen skin prick test (SPT). Participants were either SPT negative (0mm wheal) or SPT positive (1-4 mm wheal). Participants were then randomized into treatment groups within each stratum. This configuration was preserved in LEAP-On (this trial)

Reporting Groups
  Description
Continued Peanut Avoidance Group In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
Peanut Avoidance After Peanut Consumption Group In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume 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. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.

Participant Flow:   Overall Study
    Continued Peanut Avoidance Group   Peanut Avoidance After Peanut Consumption Group
STARTED   282   274 
COMPLETED   278   269 
NOT COMPLETED   4   5 
Withdrawal by Subject                2                0 
Communication Difficulties                1                5 
Scheduling Conflicts                1                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]
 235   228   47   46   556 
Age, Customized 
[Units: Months]
Mean (Standard Deviation)
         
Age in Months   61.0  (3.44)   61.7  (4.19)   60.6  (3.76)   61.4  (4.98)   61.3  (3.93) 
Gender 
[Units: Participants]
Count of Participants
         
Female      85  36.2%      102  44.7%      14  29.8%      18  39.1%      219  39.4% 
Male      150  63.8%      126  55.3%      33  70.2%      28  60.9%      337  60.6% 
Region of Enrollment 
[Units: Participants]
         
United Kingdom   235   228   47   46   556 


  Outcome Measures
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1.  Primary:   Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum   [ Time Frame: 72 months ]

2.  Primary:   Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group   [ Time Frame: 72 months ]

3.  Primary:   Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum in the Per Protocol Population   [ Time Frame: 72 months ]

4.  Primary:   Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group in the Per Protocol Population   [ Time Frame: 72 months ]

5.  Secondary:   Proportion of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group   [ Time Frame: 60 months and 72 months ]

6.  Secondary:   Proportion of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population   [ Time Frame: 60 months and 72 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: NCT01366846     History of Changes
Other Study ID Numbers: DAIT ITN049AD
Study First Received: June 2, 2011
Results First Received: November 8, 2016
Last Updated: November 8, 2016
Health Authority: United States: Federal Government
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee