Persistence of Oral Tolerance to Peanut (LEAP-On)

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 2

Conditions: Food Allergy; Hypersensitivity; Eczema; Egg Allergy

Treatments: Other: Avoidance of peanut

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT01366846

DAIT ITN049AD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 556 patients

Sex: All

Ages: 5 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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556 participants in 2 patient groups

Peanut avoidance after continuous peanut consumption

Experimental group

Description:

These participants were the peanut consumption group of the ITN032AD (LEAP) study

Treatment:

Other: Avoidance of peanut

Continued peanut avoidance

Experimental group

Description:

These participants were the peanut avoidance group of the ITN032AD (LEAP) study

Treatment:

Other: Avoidance of peanut