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
NCT number | NCT06273605 |
Other study ID # | 102828 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 9, 2024 |
Est. completion date | August 30, 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Murdoch Children's Research Institute (MCRI) | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Murdoch Childrens Research Institute |
Australia,
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
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 |
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