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

NCT06273605 | Active Not Recruiting DMC

• 1 other identifier: 102828
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Food Allergy in Infants

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• 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)

  Baseline, 12 months

• 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)

  Baseline, 12 months

• Heath care costs

  12 months

Study Arms (1)

Egg Ladder

OTHER

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: Egg Ladder

Interventions

Egg Ladder OTHER

12 month protocol of graded and gradual egg introduction

Egg Ladder

Eligibility Criteria

• Age: 4 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Murdoch Children's Research Institute (MCRI)

Melbourne, Victoria, 3052, Australia

Location

Related Publications (4)

• McAdams SA, Cordeiro ML. Simple selected ion monitoring capillary gas chromatographic-mass spectrometric method for the determination of cotinine in serum, urine and oral samples. J Chromatogr. 1993 May 19;615(1):148-53. doi: 10.1016/0378-4347(93)80301-j.

  PMID: 8340453 BACKGROUND

• Bettocchi S, Di Vagno G, Cormio G, Selvaggi L. Intra-abdominal spread of malignant cells following hysteroscopy. Gynecol Oncol. 1997 Jul;66(1):165-6. doi: 10.1006/gyno.1997.4654. No abstract available.

  PMID: 9234941 BACKGROUND

• 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.

  PMID: 25613427 BACKGROUND

• 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.

  PMID: 34586690 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Vicki McWilliam, PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 22, 2024
• Study Start: April 9, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication of the primary outcome
• Access Criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the Egg Up trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered.

Locations

AU (1)