Trial Review

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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.
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.
Secondary ID [1] 251694 0
Nil
Universal Trial Number (UTN)
Trial acronym
STEP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
egg allergy 257309 0
Condition category
Condition code
Inflammatory and Immune System 257453 257453 0 0
Allergies

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 256434 0
Prevention
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).
Control group
Placebo

Outcomes
Primary outcome [1] 258374 0
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.
Timepoint [1] 258374 0
At 12 months of age
Secondary outcome [1] 264107 0
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.
Timepoint [1] 264107 0
At 12 months of age
Secondary outcome [2] 264108 0
The development of underlining humoral and cellular immune development. This will be assessed through blood sample analysis.
Timepoint [2] 264108 0
At 12 months of age

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/05/2010
Actual
12/01/2011
Date of last participant enrolment
Anticipated
19/12/2014
Actual
12/11/2014
Date of last data collection
Anticipated
8/12/2017
Actual
28/05/2015
Sample size
Target
1194
Accrual to date
Final
820
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment postcode(s) [1] 2881 0
5006
Recruitment postcode(s) [2] 2880 0
5042
Recruitment postcode(s) [3] 2882 0
6008

Funding & Sponsors
Funding source category [1] 256929 0
Government body
Name [1] 256929 0
National Health and Medical Research Council
Country [1] 256929 0
Australia
Primary sponsor type
Other
Name
Women's and Children's Health Research Institute
Address
Level 7 Clarence Reiger Building
Women's and Children's Hospital
72 King William Rd North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 256195 0
University
Name [1] 256195 0
University of Western Australia (WA)
Address [1] 256195 0
Department of Paediatrics and Child Health
University of Western Australia
Roberts Rd
Subiaco WA 6008
Country [1] 256195 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258933 0
Children, Youth and Women's Health Service
Ethics committee address [1] 258933 0
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 258933 0
Australia
Date submitted for ethics approval [1] 258933 0
20/01/2010
Approval date [1] 258933 0
07/04/2010
Ethics approval number [1] 258933 0
REC 2245/2/13

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 31134 0
Prof Maria Makrides
Address 31134 0
Women's and Children's Health Research Institute
Level 7
Women's and Children's Hospital
King William Rd
North Adelaide SA 5006
Country 31134 0
Australia
Phone 31134 0
+61 8 8161 6067
Fax 31134 0
Email 31134 0
maria.makrides@health.sa.gov.au
Contact person for public queries
Name 14381 0
Dr Debbie Palmer
Address 14381 0
Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008
Country 14381 0
Australia
Phone 14381 0
+61 8 9340 8681
Fax 14381 0
+61 8 9388 2097
Email 14381 0
debbie.palmer@uwa.edu.au
Contact person for scientific queries
Name 5309 0
Dr Debbie Palmer
Address 5309 0
Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008
Country 5309 0
Australia
Phone 5309 0
+61 8 9340 8681
Fax 5309 0
+61 8 9388 2097
Email 5309 0
debbie.palmer@uwa.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseLongitudinal egg-specific regulatory T- and B-cell development: Insights from primary prevention clinical trials examining the timing of egg introduction.2021https://dx.doi.org/10.1111/all.14621
Dimensions AIRandomized controlled trial of early regular egg intake to prevent egg allergy2016https://doi.org/10.1016/j.jaci.2016.06.052
N.B. These documents automatically identified may not have been verified by the study sponsor.