protocolSection identificationModule nctId: NCT06273605, orgStudyIdInfo id: 102828, briefTitle: The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2025-08-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Murdoch Childrens Research Institute, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Food Allergy, conditions: Food Allergy in Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Egg Ladder, outcomesModule primaryOutcomes measure: 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., primaryOutcomes measure: 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., primaryOutcomes measure: 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., primaryOutcomes measure: 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., primaryOutcomes measure: 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., primaryOutcomes measure: Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis, secondaryOutcomes measure: 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), secondaryOutcomes measure: 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), secondaryOutcomes measure: Heath care costs, eligibilityModule sex: ALL, minimumAge: 4 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Murdoch Children's Research Institute (MCRI), status: RECRUITING, city: Melbourne, state: Victoria, zip: 3052, country: Australia, contacts name: Vicki McWilliam, PhD, role: CONTACT, phone: 0418588953, email: vicki.mcwilliam@rch.org.au, contacts name: Kirsten Perrett, MD, PhD, role: CONTACT, email: kirsten.perrett@rch.org.au, geoPoint lat: -37.814, lon: 144.96332, hasResults: False