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Persistence of Oral Tolerance to Peanut (LEAP-On)

This study is enrolling participants by invitation only.
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: January 8, 2013
Last verified: January 2013
History of Changes

June 2, 2011
January 8, 2013
December 2012
February 2015   (final data collection date for primary outcome measure)
Proportion of participants with peanut allergy in the peanut avoidance after continuous peanut consumption group and the continued peanut avoidance group [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
Comparison of the proportion of peanut allergy between both groups will be made allowing for the evaluation of whether the early consumption of peanut induces a state of 'persistent tolerance'.
Proportion of participants with peanut allergy at year 6 in the group who consumed peanut and the group who avoided peanut in the LEAP Study [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01366846 on ClinicalTrials.gov Archive Site
  • Proportion of participants with peanut allergy in the peanut avoidance after continuous peanut consumption group [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
    The within group comparison in peanut avoidance after continuous peanut consumption between year 5 and year 6 will allow the identification and statistical evaluation of a group of children with 'transient desensitisation'.
  • Proportion of subjects with allergic sensitization to selected ingested and inhaled allergens, and with seasonal rhino-conjunctivitis, perennial rhinoconjunctivitis, and asthma. [ Time Frame: Year 6 ] [ Designated as safety issue: No ]
  • Incidence of adverse events, and nutritional evaluations. [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
  • Proportion of participants with peanut allergy at year 6 in the group who consumed peanut in the LEAP Study [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with allergic sensitization to selected ingested and inhaled allergens, and with seasonal rhino-conjunctivitis, perennial rhinoconjunctivitis, and asthma. [ Time Frame: Year 6 ] [ Designated as safety issue: No ]
  • Incidence of adverse events, and nutritional evaluations. [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
  • Results of cellular and humoral assessments of immune response related to the development of allergy or tolerance to specific allergens. [ Time Frame: Year 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Persistence of Oral Tolerance to Peanut
The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis (LEAP-On) (ITN049AD)

ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).

Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Eczema
  • Egg Allergy
  • Food Allergy
  • Hypersensitivity
Other: Avoidance of peanut
All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.
  • Experimental: Peanut avoidance after continous peanut consumption
    These participants were the peanut consumption group of the ITN032AD (LEAP) study
    Intervention: Other: Avoidance of peanut
  • Experimental: Continued peanut avoidance
    These participants were the peanut avoidance group of the ITN032AD (LEAP) study
    Intervention: Other: Avoidance of peanut
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
635
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP Study criteria.
  • Parent or guardian willing to provide informed consent.

Exclusion Criteria:

  • Unable or unwilling to comply with study intervention and procedures.
  • Participation in other food allergy intervention trials.
Both
5 Years to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01366846
DAIT ITN049AD
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Study Chair: Gideon Lack, MD Evelina Children's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
January 2013

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