ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

STEP Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

egg allergy

Condition category

Condition code

Inflammatory and Immune System

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]

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]

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]

At 12 months of age

Secondary outcome [1]

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]

At 12 months of age

Secondary outcome [2]

The development of underlining humoral and cellular immune development. This will be assessed through blood sample analysis.

Timepoint [2]

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]

5042

Recruitment postcode(s) [2]

5006

Recruitment postcode(s) [3]

6008

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 9848
Canberra ACT 2601

Country [1]

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]

University

Name [1]

University of Western Australia (WA)

Address [1]

Department of Paediatrics and Child Health
University of Western Australia
Roberts Rd
Subiaco WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children, Youth and Women's Health Service

Ethics committee address [1]

Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/01/2010

Approval date [1]

07/04/2010

Ethics approval number [1]

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

Prof Maria Makrides

Address

Women's and Children's Health Research Institute
Level 7
Women's and Children's Hospital
King William Rd
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 6067

Fax

maria.makrides@health.sa.gov.au

Contact person for public queries

Name

Debbie Palmer

Address

Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8681

Fax

+61 8 9388 2097

debbie.palmer@uwa.edu.au

Contact person for scientific queries

Name

Debbie Palmer

Address

Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road, Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8681

Fax

+61 8 9388 2097

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

Source	Title	Year of Publication	DOI
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
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

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically