Main Trial: Difference between the Multi-nut OIT Group in comparison to the Standard Care Group in the proportion and severity of reported adverse events (AE) related to study nut ingestion during the 18-month treatment phase
Number and severity of AEs as assessed by standardised predetermined criteria, related to study peanut/tree nut ingestion from randomisation to end of the 18-month treatment phase collected via OFC and clinic visit observations and medical history taken, and parent questionnaire diaries.
Main Trial: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in mean change from screening to 18 months in quality of life scores for the children, measured by the Food Allergy Quality of Life-Parent Form (FAQL-PF)
The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life questionnaires for patients with food allergy. The FAQL-PF completed by parents of children aged 0-12 years, consists of 30 items over 3 domains: emotional impact, food anxiety, social and dietary restrictions. Total and domain scores are calculated by dividing the sum of completed items by the number of competed items.
Main Trial: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in mean change from screening to 18 months in quality of life scores for the parents using the ICEpop CAPability measure for Adults (ICECAP-A)
The ICECAP-A questionnaire is a measure of capability well-being for adults. It has been developed in the United Kingdom (UK) using in-depth and semi-structured qualitative research with adults over the age of 18; values for the UK, obtained using best-worst scaling, are available. The instrument contains five attributes - stability, attachment, autonomy, achievement, and enjoyment, each with four levels. Research on the instrument's validity, reliability, feasibility of use and sensitivity to change are still ongoing.
Main Trial: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in mean change from screening to 18 months in State/Trait anxiety using the State/Trait Anxiety Inventory (STAI)
The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
Main Trial: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in the number of allergy-related healthcare visits from randomisation to 18 months
Captured per number of hospitalisations, Emergency Room (ER) visits, physician office visits, and medications/number of prescriptions using linked data to Medicare healthcare usage (Medical Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS)) and Victorian Data Linkage for hospital presentations (Victorian Admitted Episodes Dataset (VAED)).
Main Trial: Difference between the two groups in change in SPT wheal size at screening and at 18 months
Measured by SPT wheal size for each child's study nuts at screening and at 18 months.
Main Trial: Difference between the two groups in change in levels of specific Immunoglobulin E (sIgE) at screening and at 18 months
Measured by levels of sIgE for each child's study nuts at screening and at 18 months.
Main Trial: Difference between the two groups in change in levels of specific Immunoglobulin G4 (sIgG4) at screening and at 18 months
Measured by levels of sIgG4 for each child's study nuts at screening and at 18 months.
Main Trial: Difference between the two groups in change in levels of component-resolved diagnostic (CRD) at screening and at 18 months
Measured by levels of CRD for each child's study nuts at screening and at 18 months. CRD is an approach utilised to characterize the molecular components of each allergen involved in a sIgE-mediated response.
Main Trial: Difference between the two groups in change in levels of basophil activation test (BAT) at screening and at 18 months
Measured by levels of BAT for each child's study nuts at screening and at 18 months.
Main Trial: Total number of missed doses overall (all participants) in the Multi-Nut OIT Group over the 18 month treatment phase
Compliance will be measured by daily parent diary records of doses consumed. Total number of missed daily doses overall (all participants).
Main Trial: Mean number of missed daily doses per participant in the Multi-Nut OIT Group over the 18 month treatment phase
Compliance will be measured by daily parent diary records of doses consumed. Total number of missed daily doses averaged per participant.
Main Trial Ad Libitum Phase: Comparison of the number of participants who pass their OFC after the 12 month Ad Libitum phase for both study nuts between the Multi-Nut OIT Group and Standard Care Group
In both groups, passing requires tolerating all OFC doses for both of their study nuts.
Main Trial Ad Libitum Phase: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in the proportion and severity of reported AEs related to study nut ingestion during the 12-month Ad libitum phase
Number and severity of AEs as assessed by standardised predetermined criteria, related to study peanut/tree nut ingestion from the start to the end of the 12-month Ad libitum phase collected via end of trial OFC observation and medical history, and parent 1-monthly questionnaires.
Main Trial: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in mean change from the start to the end of the Ad libitum phase in quality of life scores for the children, measured by the FAQL-PF
The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life questionnaires for patients with food allergy. The FAQL-PF completed by parents of children aged 0-12 years, consists of 30 items over 3 domains: emotional impact, food anxiety, social and dietary restrictions. Total and domain scores are calculated by dividing the sum of completed items by the number of competed items.
Main Trial Ad Libitum Phase: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in mean change from the start to the end of the Ad libitum phase in quality of life scores for the parents using the ICECAP-A
The ICECAP-A questionnaire is a measure of capability well-being for adults. It has been developed in the UK using in-depth and semi-structured qualitative research with adults over the age of 18; values for the UK, obtained using best-worst scaling, are available. The instrument contains five attributes - stability, attachment, autonomy, achievement, and enjoyment, each with four levels. Research on the instrument's validity, reliability, feasibility of use and sensitivity to change are still ongoing.
Main Trial Ad Libitum Phase: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in mean change from the start to the end of the Ad libitum phase in State/Trait anxiety using the STAI
The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
Main Trial Ad Libitum Phase: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in the number of allergy-related healthcare visits during the 12-month Ad libitum phase
Captured per number of hospitalisations, ER visits, physician office visits, and medications/number of prescriptions using linked data to Medicare healthcare usage (MBS/PBS) and Victorian Data Linkage for hospital presentations (VAED)
Main Trial Ad Libitum Phase: Difference between the two groups in change in SPT wheal size from 18-months treatment phase assessment to the 12-month Ad libitum phase assessment
Measured by SPT wheal size for each child's study nuts at the 18-month treatment phase assessment and at the 12-month Ad libitum phase assessment.
Main Trial Ad Libitum Phase: Difference between the two groups in change in levels of sIgE from 18-months treatment phase assessment to the 12-month Ad libitum phase assessment
Measured by levels of sIgE each child's study nuts at the 18-month treatment phase assessment and at the 12-month Ad libitum phase assessment.
Main Trial Ad Libitum Phase: Difference between the two groups in change in levels of sIgG4 from 18-months treatment phase assessment to the 12-month Ad libitum phase assessment
Measured by levels of sIgG4 for each child's study nuts at the 18-month treatment phase assessment and at the 12-month Ad libitum phase assessment.
Main Trial Ad Libitum Phase: Difference between the two groups in change levels of CRD from 18-months treatment phase assessment to the 12-month Ad libitum phase assessment
Measured by levels of CRD for each child's study nuts at the 18-month treatment phase assessment and at the 12-month Ad libitum phase assessment. CRD is an approach utilised to characterize the molecular components of each allergen involved in a sIgE-mediated response.
Main Trial Ad Libitum Phase: Difference between the two groups in change levels of BAT from 18-months treatment phase assessment to the 12-month Ad libitum phase assessment
Measured by levels of BAT for each child's study nuts at the 18-month treatment phase assessment and at the 12-month Ad libitum phase assessment.
Main Trial Ad Libitum Phase: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in the amount of study nut consumption during the Ad libitum phase
Amount of study nut consumption during the Ad libitum phase based on parent 1-monthly questionnaires.
Main Trial Ad Libitum Phase: Difference between the Multi-Nut OIT Group in comparison to the Standard Care Group in the frequency of study nut consumption during the Ad libitum phase
Frequency of study nut consumption during the Ad libitum phase based on parent 1-monthly questionnaires.
Pilot Phase: Number of children at screening who refuse, are eligible, or are ineligible
Pilot Phase: At screening, number of children who:
refuse to participate
are eligible
are ineligible (and reason)
Pilot Phase: Number of children at recruitment who agree or refuse to participate
At recruitment, number of eligible children who:
agree to be in the study
who refuse to be in the study
Pilot Phase: Number of participants in the Multi-Nut OIT Group who complete escalation
Number of children in the Multi-Nut OIT Group who complete all escalation doses
Pilot Phase: Number of participants in the Multi-Nut OIT Group who complete the build-up phase
Number of participants in the Multi-Nut OIT Group who complete build-up
Pilot Phase: Number of participants in the Multi-Nut OIT Group and the Standard Care Group who withdraw, discontinue, and/or experience 1 or more protocol violations
Number of participants in either arm who:
withdraw
discontinue the treatment prior to 18 months
experience 1 or more protocol violations
Pilot Phase: Number and severity of AEs during the screening OFC for all participants
Number and severity of AEs as assessed by standardised predetermined criteria during the screening OFC.
Pilot Phase: Number and severity of AEs for the Multi-Nut OIT Group during escalation
Number and severity of AEs as assessed by standardised predetermined criteria during escalation.
Pilot Phase: Number and severity of AEs for the Multi-Nut OIT Group during the build-up phase
Number and severity of AEs as assessed by standardised predetermined criteria during build-up.
Pilot Phase: Total number of missed doses overall (all participants) in the Multi-Nut OIT Group over the build-up phase
Based on parent diary entries. Number of missed daily doses overall (all participants).
Pilot Phase: Mean number of missed daily doses per participant in the Multi-Nut OIT Group over the build-up phase
Based on parent diary entries. Number of missed daily doses averaged per participant.