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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06273605
Registration number
NCT06273605
Ethics application status
Date submitted
1/02/2024
Date registered
22/02/2024
Date last updated
17/04/2024
Titles & IDs
Public title
The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy
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Scientific title
Is the Use of Home-based, Dietitian-led "Egg Ladders" as a Treatment Pathway for Newly Diagnosed Infants With Immunoglobulin E (IgE) Mediated Egg Allergy Safe and Feasible? The ADAPT Program - Egg Up: A Prospective Clinical Trial
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Secondary ID [1]
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102828
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Food Allergy
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Food Allergy in Infants
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Condition category
Condition code
Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Egg Ladder
Other: Egg Ladder - An egg ladder is a form of home-based dietary advancement therapy that aims to facilitate the development of natural tolerance through the gradual introduction of egg containing foods with increasing quantity and allergenicity through different cooking processes. This intervention involves 5 steps over a 12 month period 1.baked egg, 2.well-cooked egg as an ingredient, 3. well cooked whole egg, 4. lightly cooked whole egg and 5.then raw egg.
Other interventions: Egg Ladder
12 month protocol of graded and gradual egg introduction
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number and severity of adverse events related to baked egg ingestion (step 1) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
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Assessment method [1]
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Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 1 of the egg ladder - baked egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
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Timepoint [1]
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12 months
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Primary outcome [2]
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Number and severity of adverse events related to ingestion of well cooked egg as an ingredient (step 2) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
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Assessment method [2]
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Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 2 of the egg ladder - well cooked egg as an ingredient) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
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Timepoint [2]
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12 months
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Primary outcome [3]
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Number and severity of adverse events related ingestion of well cooked whole egg (step 3) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
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Assessment method [3]
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Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 3 of the egg ladder - well cooked whole egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
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Timepoint [3]
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12 months
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Primary outcome [4]
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Number and severity of adverse events related to ingestion of lightly cooked whole egg (step 4) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
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Assessment method [4]
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Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 4 of the egg ladder - lightly cooked whole egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
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Timepoint [4]
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12 months
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Primary outcome [5]
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Number and severity of adverse events related to raw egg ingestion (step 5) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
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Assessment method [5]
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Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 5 of the egg ladder - raw egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
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Timepoint [5]
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12 months
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Primary outcome [6]
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Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis
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Assessment method [6]
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Feasibility will be determined via clinician and parent questionnaires which will measure barriers to utilizing the egg ladder as a treatment pathway for newly diagnosed egg allergy.
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Timepoint [6]
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12 months
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Secondary outcome [1]
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Change from baseline (diagnosis) in parent reported Quality of Life scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) to study completion (12 months from diagnosis)
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Assessment method [1]
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The Food Allergy Quality of Life Questionnaire (FAQLQ-PF) is used for assessing the Quality of Life of children with food allergies aged 0-12 years from their parents report. It gives a total mean score consisting of scores of 3 subscales: emotional impact, food anxiety, and social and dietary limitations. The FAQLQ-PF is scored using a 7-point Likert scales from 0 to 6 - a higher score indicates worse FAQL for the recall period.
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Timepoint [1]
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Baseline, 12 months
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Secondary outcome [2]
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Change from baseline (diagnosis) in parental anxiety scores measured using the Impairment Measure for Parental Food Allergy - Associated Anxiety and Coping Tool (IMPAACT) to study completion (12 months from diagnosis)
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Assessment method [2]
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The Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT) is a validated 28-item self-report questionnaire for assessing food allergy-specific anxiety in the caregivers of children with food allergy. Items are completed on a 7-point Likert scale and summed to yield a total food allergy-specific anxiety score. Total IMPAACT scores range from 0 to 196 with the higher the score the greater the level of anxiety.
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Timepoint [2]
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Baseline, 12 months
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Secondary outcome [3]
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Heath care costs
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Assessment method [3]
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Total cost of allergy related healthcare during the home-based egg ladder intervention with dietitian support from baseline (diagnosis) to study completion (12 months from diagnosis) compared to the current model of care at the Royal Children's Hospital Allergy clinic.
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Timepoint [3]
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12 months
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Eligibility
Key inclusion criteria
- infants aged greater than 4 months and less than 12 months of age diagnosed by an RCH
allergist with IgE- mediated egg allergy in conjunction with a positive skin prick
test (SPT) or specific immunoglobulin E (sIgE) to egg white
- has a legally acceptable representative capable of understanding the informed consent
document and providing consent on the participants behalf
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Minimum age
4
Months
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Maximum age
12
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- any history of severe food induced anaphylaxis. Defined as reaction requiring 2 doses
of intermuscular adrenalin
- Physician diagnosed recurrent wheeze
- Not commenced or unable to eat solid food
- prescribed beta-blocker medication
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Murdoch Children's Research Institute (MCRI) - Melbourne
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this study is to test the safety and feasibility of a change in management
approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg
allergy will have egg introduced via a gradual and graded home based approach known as an
"egg ladder" supervised by a dietitian. The main questions this study aims to answer are how
safe and feasible are home-based dietitian-led "egg ladders" as a treatment pathway to
achieve tolerance of egg for newly diagnosed infants with egg allergy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06273605
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Trial related presentations / publications
Chomyn A, Chan ES, Yeung J, Vander Leek TK, Williams BA, Soller L, Abrams EM, Mak R, Wong T. Canadian food ladders for dietary advancement in children with IgE-mediated allergy to milk and/or egg. Allergy Asthma Clin Immunol. 2021 Aug 5;17(1):83. doi: 10.1186/s13223-021-00583-w.
De Vlieger L, Nuyttens L, Matton C, Diels M, Verelst S, Leus J, Coppens K, Sauer K, Dilissen E, Coorevits L, Matthys C, Schrijvers R, Raes M, Bullens DMA. Guided Gradual Egg-Tolerance Induction in Hen's Egg Allergic Children Tolerating Baked Egg: A Prospective Randomized Trial. Front Allergy. 2022 May 11;3:886094. doi: 10.3389/falgy.2022.886094. eCollection 2022.
Koplin JJ, Wake M, Dharmage SC, Matheson M, Tang ML, Gurrin LC, Dwyer T, Peters RL, Prescott S, Ponsonby AL, Lowe AJ, Allen KJ; HealthNuts study group. Cohort Profile: The HealthNuts Study: Population prevalence and environmental/genetic predictors of food allergy. Int J Epidemiol. 2015 Aug;44(4):1161-71. doi: 10.1093/ije/dyu261. Epub 2015 Jan 21.
Leech SC, Ewan PW, Skypala IJ, Brathwaite N, Erlewyn-Lajeunesse M, Heath S, Ball H, James P, Murphy K, Clark AT. BSACI 2021 guideline for the management of egg allergy. Clin Exp Allergy. 2021 Oct;51(10):1262-1278. doi: 10.1111/cea.14009. Erratum In: Clin Exp Allergy. 2022 Jan;52(1):211.
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Public notes
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Contacts
Principal investigator
Name
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Vicki McWilliam, PhD
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Address
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Murdoch Childrens Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Vicki McWilliam, PhD
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Address
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Country
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Phone
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0418588953
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06273605
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