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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06273605




Registration number
NCT06273605
Ethics application status
Date submitted
1/02/2024
Date registered
22/02/2024

Titles & IDs
Public title
The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy
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
Secondary ID [1] 0 0
102828
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 0 0
Food Allergy in Infants 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis
Timepoint [6] 0 0
12 months
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline, 12 months
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Baseline, 12 months
Secondary outcome [3] 0 0
Heath care costs
Timepoint [3] 0 0
12 months

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
Minimum age
4 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute (MCRI) - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vicki McWilliam, PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vicki McWilliam, PhD
Address 0 0
Country 0 0
Phone 0 0
0418588953
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data set collected for this analysis of the Egg Up trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. 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. Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research institute which has approved the proposed analysis plan.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
6 months after publication of the primary outcome
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06273605