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Trial registered on ANZCTR


Registration number
ACTRN12609000415202
Ethics application status
Approved
Date submitted
8/05/2009
Date registered
5/06/2009
Date last updated
10/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal timing of solid food introduction to infants at high risk of developing allergic disease.
Scientific title
In infants with eczema the commencement of dietary egg intake from 4 months of age will be compared to the commencement age of 8 months on the outcome of egg allergy at 12 months of age.
Secondary ID [1] 273146 0
PMH Ethics Number 1635-EP
Universal Trial Number (UTN)
Trial acronym
STAR Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Egg allergy 4741 0
Eczema 4742 0
Condition category
Condition code
Inflammatory and Immune System 237073 237073 0 0
Allergies
Skin 237269 237269 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 teaspoon of whole egg powder given orally once per day from 4 to 8 months of age. Cooked egg containing foods will be included in the infant's diet orally from 8-12 months (there will be no specified egg dose from 8-12 months of age as this will depend on family dietary practices).
Intervention code [1] 4513 0
Prevention
Comparator / control treatment
1 teaspoon of rice powder given orally once per day from 4 to 8 months of age. Cooked egg containing foods will be included in the infant's diet orally from 8-12 months of age (there will be no specified egg dose from 8-12 months of age as this will depend on family dietary practices).
Control group
Placebo

Outcomes
Primary outcome [1] 5910 0
Immunoglobulin E (IgE) mediated egg allergy defined as an allergic reaction to a raw egg challenge and associated evidence of sensitisation to egg assessed by skin prick testing where a positive skin prick test has a mean weal diameter >3mm to egg. An allergic reaction will be defined as at least 3 concurrent non-contact urticaria persisting for at least 5 minutes and/or generalised skin erthema and/or vomiting and/or anaphylaxis (evidence of circulatory or respiratory involvement) within 2 hours of ingestion of raw egg
Timepoint [1] 5910 0
At 12 months of age
Secondary outcome [1] 241962 0
Egg allergy defined as a medically observed allergic reaction to oral cooked egg exposure. An allergic reaction will be defined as at least 3 concurrent non-contact urticaria persisting for at least 5 minutes and/or generalised skin erthema and/or vomiting and/or anaphylaxis (evidence of circulatory or respiratory involvement) within 2 hours of ingestion of the cooked egg
Timepoint [1] 241962 0
At 8 months of age
Secondary outcome [2] 241963 0
Eczema severity using a standardised scoring system for atopic dermatitis/eczema(SCORAD)
Timepoint [2] 241963 0
At 8 months of age
Secondary outcome [3] 241964 0
The development of underlining and humoral and cellular immune development. This will be assessed through blood sample analysis.
Timepoint [3] 241964 0
At 12 months of age
Secondary outcome [4] 241965 0
Food allergy and/or sensitisation to allergenic foods (other than egg). Sensitisation will be defined as a positive skin prick test with mean weal diameter >3mm to a food allergen. A food allergy reaction will be defined as at least 3 concurrent non-contact urticaria persisting for at least 5 minutes and/or generalised skin erthema and/or vomiting and/or anaphylaxis (evidence of circulatory or respiratory involvement) within 2 hours of ingestion of a particular food.
Timepoint [4] 241965 0
At 12 months of age

Eligibility
Key inclusion criteria
Term singleton infants
Infants with symptoms of moderate to severe eczema
Both breastfed and formula fed infants
Minimum age
0 Months
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
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 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 a 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 4 months of age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
18/05/2009
Actual
15/07/2009
Date of last participant enrolment
Anticipated
Actual
7/09/2011
Date of last data collection
Anticipated
Actual
25/05/2012
Sample size
Target
226
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment postcode(s) [1] 1680 0
5006
Recruitment postcode(s) [2] 1681 0
6008

Funding & Sponsors
Funding source category [1] 4921 0
Charities/Societies/Foundations
Name [1] 4921 0
Women's and Children's Hospital Foundation
Country [1] 4921 0
Australia
Primary sponsor type
Other
Name
Women's and Children's Health Research Insitute
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] 4450 0
University
Name [1] 4450 0
Department of Paediatrics and Child Health University of WA
Address [1] 4450 0
Roberts Rd
Subiaco WA 6008
Country [1] 4450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6990 0
Children, Youth and Women's Health Service
Ethics committee address [1] 6990 0
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 6990 0
Australia
Date submitted for ethics approval [1] 6990 0
Approval date [1] 6990 0
30/03/2009
Ethics approval number [1] 6990 0
REC2142/2/12
Ethics committee name [2] 6991 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [2] 6991 0
Princess Margaret Hospital for Children
Roberts Rd Subiaco WA 6008
Ethics committee country [2] 6991 0
Australia
Date submitted for ethics approval [2] 6991 0
Approval date [2] 6991 0
16/04/2009
Ethics approval number [2] 6991 0
1635/EP

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 months compared to the more common practice of egg avoidance until 8 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
Primary trial publication:
DJ Palmer, J Metcalfe, M Makrides, MS Gold, P Quinn, CE West, R Loh, SL Prescott. Early regular egg exposure in infants with eczema: a randomized controlled trial. J Allergy Clin Immunol 2013; 132(2): 387-92.e1.

Secondary trial publication:
JR Metcalfe, N D’Vaz, M Makrides, MS Gold, P Quinn, CE West, R Loh, SL Prescott, DJ Palmer. Elevated IL-5 and IL-13 responses to egg proteins predate the introduction of egg in solid foods in infants with eczema. Clin Exp Allergy 2016;46(2):308-16.
Public notes

Contacts
Principal investigator
Name 29586 0
Dr Debbie Palmer
Address 29586 0
Childhood Allergy and Immunology Research School of Paediatrics and Child Health University of Western Australia Roberts Road, Subiaco WA 6008
Country 29586 0
Australia
Phone 29586 0
+61 8 9340 8681
Fax 29586 0
Email 29586 0
[email protected]
Contact person for public queries
Name 12833 0
Debbie Palmer
Address 12833 0
Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008
Country 12833 0
Australia
Phone 12833 0
+61 8 9340 8681
Fax 12833 0
+61 8 9388 2097
Email 12833 0
[email protected]
Contact person for scientific queries
Name 3761 0
Debbie Palmer
Address 3761 0
Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008
Country 3761 0
Australia
Phone 3761 0
+61 8 9340 8681
Fax 3761 0
+61 8 9388 2097
Email 3761 0
[email protected]

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
EmbaseElevated IL-5 and IL-13 responses to egg proteins predate the introduction of egg in solid foods in infants with eczema.2016https://dx.doi.org/10.1111/cea.12608
N.B. These documents automatically identified may not have been verified by the study sponsor.