The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy

Food Allergy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273605
• Other study ID #: 102828
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: Murdoch Childrens Research Institute
• Contact: Vicki McWilliam, PhD
• Phone: 0418588953
• Email: vicki.mcwilliam[@]rch.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This prospective trial will evaluate the safety and feasibility of a change in practice for infants with newly diagnosed IgE-mediated egg allergy managed by the Department of Allergy and Immunology at the Royal Children's Hospital (RCH). Children <12 months of age with clinician diagnosed IgE-mediated egg allergy, who do not have a history of severe anaphylaxis to egg will be offered cautious, home-based egg introduction via a standardised 'egg ladder' protocol with dietitian support. An egg ladder is a form of dietary advancement therapy that aims to facilitate the development of natural tolerance through the gradual introduction of egg with increasing allergenicity and quantity. Although increasingly becoming widespread in clinical practice, this is yet to be evaluated in Australia via a prospective study. The HealthNuts cohort study has shown that 80% of 12-month-old infants tolerate baked egg (eg in a muffin) and 47% have naturally outgrown their egg allergy (tolerating raw egg) by 2 years of age which was 1 year from their egg allergy diagnosis.

Current practice at RCH allergy clinic for infants with egg allergy is to recommend they avoid all forms of egg until 2 years when an inpatient baked egg challenge in the form of a muffin may be offered. If passed, the children can include baked egg products at home but must avoid cooked and raw egg until a resolution challenge is offered 12 months later (cooked egg in the form of well-cooked scrambled egg). Raw egg hospital challenges are no longer offered at RCH. Review of the inpatient challenges at RCH undertaken from January - June 2023 found the median age for a baked egg challenge was 5 years and a cooked egg challenge was 4 years with a current waitlist of 1200 patients. This current model of care is prolonging the burden of food allergy management for these families for years beyond the time where resolution has likely to have occurred in the overwhelming majority. Furthermore, children are reviewed by the Allergy physician yearly if diagnosed <12 months of age and then every 2 years after that, which adds further pressure to outpatient waitlists for allergy clinics.

We will establish the safety of our 'egg ladder' protocol by collecting adverse events (AE) from baseline (egg allergy diagnosis) to final follow up (12 months after egg allergy diagnosis). The feasibility will be determined by the proportion of children who complete all stages of the egg ladder at 12 months from their diagnosis (egg allergy resolution). Barriers to completing the egg ladder protocol, parent reported quality of life and anxiety will be captured from baseline to final follow up 12 months after egg allergy diagnosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 12 Months

Eligibility

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

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

Related Conditions & MeSH terms

• Egg Hypersensitivity
• Food Allergy
• Food Allergy in Infants
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Egg Ladder
12 month protocol of graded and gradual egg introduction

Locations

Country	Name	City	State
Australia	Murdoch Children's Research Institute (MCRI)	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute

Country where clinical trial is conducted

Australia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	12 months
Primary	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.	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.	12 months
Primary	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.	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.	12 months
Primary	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.	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.	12 months
Primary	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.	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.	12 months
Primary	Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis	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.	12 months
Secondary	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)	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.	Baseline, 12 months
Secondary	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)	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.	Baseline, 12 months
Secondary	Heath care costs	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.	12 months