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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: March 8, 2016
Last verified: March 2016

June 2, 2011
March 8, 2016
December 2012
May 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 (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.

This is a two-sample comparison employing all available study participants in both arms of the LEAP (NCT00329784) study at visit 72. After obtaining informed consent, LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into this study, the LEAP-On (NCT01366846) Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B).

At V72, after 12 months of this new intervention, all participants will have skin prick testing (SPT), specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). For participants who do not have an oral challenge or an oral challenge at V72 with a determinate outcome, the following criteria will be used to determine their outcome at V72:

  • If the participant is tolerant and has an IgE > 0.1 and/or SPT > 0 mm at V60, the participant will be considered non-evaluable and will not be included in the analysis.
  • For all other participants, the V60 outcome will be applied to the V72 outcome (last observation carried forward).

Predictive values of peanut-specific IgE and/or SPT will not be used in the LEAP-On study because participants in the peanut consumption arm in the LEAP study are tolerating peanuts despite having high IgE and/or SPT.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
558
May 2015
May 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 (ClinicalTrials.gov ID NCT00329784) 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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01366846
DAIT ITN049AD
Yes
Yes
ITN049AD (LEAP-On) is a continuation of the ITN032AD LEAP Study. 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)
Study Chair: Gideon Lack, MD Evelina Children's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
March 2016

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