Early Reintroduction of Nuts for ImmunothErapy (ERNIE)

Not Applicable

Recruiting

• Conditions: almond allergy; cashew allergy; hazelnut allergy; walnut allergy; peanut allergy; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12622000946718
• Lead Sponsor: Child and Adolescent Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-05
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1)Male or female children from 1-4 years of age (i.e. first visit to occur on or after the participant’s first birthday, and prior to their fifth birthday).

2)Confirmed or highly probably allergy, to at least one of almond, cashew, hazelnut or walnut. Children with other nut allergies (including peanut allergy) are eligible for inclusion, however they must also have a confirmed or highly probable allergy to at least one of almond, cashew, hazelnut or walnut.

3)Parents/guardians and subjects willing to comply with all the study requirements during their participation in the study.

Tree nut allergy inclusion definitions (almond, cashew, hazelnut or walnut)
a)Confirmed (entry OFC required):
Positive SPT (mean wheal diameter >3mm) or specific IgE (>0.35 kU/L) at SV1 and allergic reaction to the tree nut during the entry OFC which meets the stopping criteria.
b)Highly probable (entry OFC not required):
i)Clinical history of anaphylaxis to the tree nut in the 12 months prior to SV1, with a positive SPT or sIgE at SV1, or
ii)Clinical history of a mild to moderate allergic reaction, with signs/symptoms meeting protocol-specified stopping criteria for OFC, to the tree nut in the 4 months prior to SV1 with a positive SPT or sIgE at SV1, or
iii)Allergic reaction during an oral food challenge to the nut in the 12 months prior to SV1 (performed as part of usual clinical care), with a positive SPT or sIgE, or
iv)For walnut only, any one of the below
(1) a skin prick test with mean wheal diameter >8mm in a participant who has no clinical history of reaction to walnut and is avoiding it in their diet, or
(2) a SPT with mean wheal diameter >6mm in a participant AND a previous clinical history of an allergic reaction to walnut prior to SV1
v)For cashew only, any two of the following three criteria:
(1)A previous clinical history of an allergic reaction to cashew prior to screening
(2)Cashew SPT >7mm mean wheal diameter
(3)Cashew component Ana o 3 specific IgE >1 kU/L

Whilst participants may have a peanut allergy alongside one or more tree nut allergies, it will not affect eligibility for the study

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:
1.History of severe anaphylaxis to any nut prior to study entry, defined as a reaction causing loss of consciousness, persistent hypoxia, or requiring more than three doses of IM adrenaline, an IV adrenaline infusion or intubation for management of an allergic reaction.
2.Use of beta-blockers
3.Participants receiving immunotherapy for food allergy, or who have received immunotherapy for food allergy in the preceding 3 months.
4.Participants currently receiving other oral or sublingual allergen immunotherapy
5.Persistent, uncontrolled asthma. In participants with asthma, symptom control will be assessed at screening using the expert opinion-based schema in the Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention, whereby uncontrolled asthma is defined as any 3 or more of the following occurring in the preceding 4 weeks
a)Daytime asthma symptoms for more than a few minutes, more than once a week
b)Any activity limitation due to asthma
c)Reliever medication needed more than once a week (excluding reliever taken before exercise)
d)Any night waking or night coughing due to asthma
Participants may be re-screened after asthma treatment is optimised.
6.Confirmed diagnosis of eosinophilic oesophagitis, and/or uncontrolled symptoms of dysphagia, postprandial abdominal pain or vomiting.
7.Children with other significant underlying medical conditions that place them at increased risk of adverse outcomes in the event of an allergic reaction, such as cardiovascular or respiratory diseases. The Principal Investigator or delegated study doctor will review these children and consult with the child’s usual treating specialist, and the Principal Investigator will confirm that the child is not at increased risk of harm from the study procedures by virtue of their underlying medical condition before enrolling the child in the study.
8.Subjects who in the opinion of the investigator will be unable to follow the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified