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Trial registered on ANZCTR
Registration number
ACTRN12610000388011
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
13/05/2010
Date last updated
7/03/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Early regular egg exposure during infancy to prevent egg allergy: a randomised controlled trial.
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Scientific title
In infants with maternal atopy the commencement of dietary egg intake from 4-6.5 months of age will be compared to the commencement age of 10 months on the outcome of immunoglobulin E (IgE) mediated egg allergy at 12 months of age.
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Secondary ID [1]
251694
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Nil
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Universal Trial Number (UTN)
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Trial acronym
STEP Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
egg allergy
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Condition category
Condition code
Inflammatory and Immune System
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1/3 teaspoon of whole egg powder mixed with 2/3 teaspoon pineapple powder and 1/4 teaspoon carrot powder will be given orally once per day from 4-6.5 months of age to 10 months of age. Cooked egg containing foods will be included in the infant's diet from 10-12 months of age (there will be no specified egg dose from 10-12 months of age as this will depend on family dietary practices).
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Intervention code [1]
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Prevention
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Comparator / control treatment
1/3 teaspoon of brown rice flour powder mixed with ~2/3 teaspoon pineapple powder and 1/4 teaspoon carrot powder will be given orally once per day from 4-6.5 months of age to 10 months of age. Cooked egg containing foods will be included in the infant's diet from 10-12 months of age (there will be no specified egg dose from 10-12 months of age as this will depend on family dietary practices).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Immunoglobulin E (IgE) mediated egg allergy defined as an allergic reaction to a pasteurised raw egg challenge and associated evidence of sensitisation to egg assessed by skin prick testing where a skin prick test has a mean weal diameter >3mm to egg.
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Assessment method [1]
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Timepoint [1]
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At 12 months of age
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Secondary outcome [1]
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Other allergic disease manifestations during infancy including the incidence of atopic eczema and IgE mediated food allergies. This will be assessed through a clinical examination and skin prick testing.
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Assessment method [1]
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Timepoint [1]
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At 12 months of age
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Secondary outcome [2]
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The development of underlining humoral and cellular immune development. This will be assessed through blood sample analysis.
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Assessment method [2]
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Timepoint [2]
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At 12 months of age
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Eligibility
Key inclusion criteria
Singleton infants born >35 weeks gestation with a birth weight >2000g. Infants with maternal atopy. Both breastfed and formula fed infants.
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Minimum age
4
Months
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Maximum age
7
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Infants who have commenced any solids prior to 4 months of age
Infants who have commenced egg containing solids prior to study entry
Infants who have developped allergic disease prior to study entry
Infants who have any congenital or acquired disease or developmental disorder likely to affect infant feeding
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Written informed consent will be obtained before participation in a screening appointment to establish trial eligibility. Each participating infant will be assigned an unique study number and randomly allocated into one of two intervention groups. Allocation is concealed by contacting the holder of the allocation schedule at a central administration site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule will be produced by an independent consultant. The schedule will be stratified by infant sex and feeding mode at trial entry.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
24/05/2010
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Actual
12/01/2011
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Date of last participant enrolment
Anticipated
19/12/2014
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Actual
12/11/2014
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Date of last data collection
Anticipated
8/12/2017
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Actual
28/05/2015
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Sample size
Target
1194
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Accrual to date
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Final
820
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment postcode(s) [1]
2880
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5042
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Recruitment postcode(s) [2]
2881
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5006
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Recruitment postcode(s) [3]
2882
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6008
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 9848
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Women's and Children's Health Research Institute
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Address
Level 7 Clarence Reiger Building
Women's and Children's Hospital
72 King William Rd North Adelaide SA 5006
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of Western Australia (WA)
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Address [1]
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Department of Paediatrics and Child Health
University of Western Australia
Roberts Rd
Subiaco WA 6008
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Children, Youth and Women's Health Service
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Ethics committee address [1]
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Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/01/2010
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Approval date [1]
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07/04/2010
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Ethics approval number [1]
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REC 2245/2/13
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Summary
Brief summary
Food allergies are common and result in a significant burden to families and the health care system. One approach to prevent food allergies may be to introduce specific foods earlier than currently recommended. The study will compare early regular introduction of egg from 4-6.5 months of age compared to the more common practice of egg avoidance until 10 months of age. If successful at reducing egg allergy, this approach will have a significant impact on reducing the burden of allergic disease.
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Trial website
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Trial related presentations / publications
1) DJ Palmer, T Sullivan, MS Gold, SL Prescott, M Makrides. Randomized controlled trial of early regular egg intake to prevent egg allergy. J Allergy Clin Immunol 2017; 139(5):1600-7,
2) DJ Palmer, T Sullivan, MS Gold, SL Prescott, M Makrides. Family characteristics modify the effect of timing of regular egg introduction on infant egg allergy. JAMA Pediatrics 2017;171(5):489-90.
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Public notes
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Contacts
Principal investigator
Name
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Prof Maria Makrides
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Address
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Women's and Children's Health Research Institute
Level 7
Women's and Children's Hospital
King William Rd
North Adelaide SA 5006
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Country
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Australia
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Phone
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+61 8 8161 6067
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Debbie Palmer
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Address
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Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008
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Country
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Australia
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Phone
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+61 8 9340 8681
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Fax
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+61 8 9388 2097
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Debbie Palmer
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Address
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Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008
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Country
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Australia
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Phone
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+61 8 9340 8681
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Fax
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+61 8 9388 2097
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Longitudinal egg-specific regulatory T- and B-cell development: Insights from primary prevention clinical trials examining the timing of egg introduction.
2021
https://dx.doi.org/10.1111/all.14621
Dimensions AI
Randomized controlled trial of early regular egg intake to prevent egg allergy
2016
https://doi.org/10.1016/j.jaci.2016.06.052
N.B. These documents automatically identified may not have been verified by the study sponsor.
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