ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000173897

Ethics application status

Approved

Date submitted

6/02/2012

Date registered

7/02/2012

Date last updated

10/02/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Can Egg Allergic Kids Eat Baked Egg? The CAKE Study.

Scientific title

Does Consumption of Baked Egg Hasten Development of Tolerance to Raw Egg in Children with Egg Allergy? - A Randomised, Controlled Trial.

Secondary ID [1]

CTN 2011/0677

Universal Trial Number (UTN)

Trial acronym

The CAKE Study

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

Children with allergy to raw egg but able to tolerate baked egg will be recruited. Participants will remain on an egg free diet, and be randomised into one of two groups. The intervention group will be provided with egg containing baked products (muffin or fruit loaf). Each participant will be asked to consume around 3 serves of the study product each week (around 30g baked egg per week). After 6 months participants will cease the product and be re challenged to raw egg at 7 months.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control group will be provided with egg free baked products (muffins or fruit loaf) that look and taste identical to the intervention products, but are egg free. Each participant will be asked to consume around 3 serves of the study product each week.

Control group

Placebo

Outcomes

Primary outcome [1]

Raw Egg Challenge

Timepoint [1]

At baseline and after 6 months of intervention.

Secondary outcome [1]

Blood test to measure immune markers of tolerance development (serum specific IgE, IgG & IgG4, and cellular immune response profiles).

Timepoint [1]

At baseline and at 6 months when intervention is ceased, and then again at 7 months prior to raw egg challenge.

Eligibility

Key inclusion criteria

IgE mediated egg allergy
Positive oral food challenge to pasteurised raw egg.
Tolerance to baked egg.

Minimum age

6 Months

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Inability to provide informed consent.
Non IgE mediated egg allergy.
Children already consuming baked egg in their diet.
FPIES, Wheat allergy.
Children with any congenital or acquired disease or developmental disorder likely to affect the ablility to undergo an oral food challenge or to consume the intervention product.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Upon consent children will be screened to ensure that they meet the inclusion criteria for the study. Children will be randomised to either treatment (baked egg) or control (egg free) and assigned a unique study ID. Allocation will involve contacting the holder of the randomisation 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 using block design will be generated by statisticians independent of study conduct. Stratified will occur for the age of the child (<2 1/2 years and 2 1/2 to 5 years 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

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

110

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Women's and Children's Hospital Foundation

Address [1]

72 King William St
North Adelaide
South Australia 5006

Country [1]

Australia

Primary sponsor type

Other

Name

Women's and Children's Health Research Institute

Address

Women's and Children's Hospital
72 King William St
North Adelaide
South Australia 5006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

72 King William Road
North Adelaide
South Australia 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/12/2011

Ethics approval number [1]

REC2400/9/14

Summary

Brief summary

Egg allergy is the most common food allergy in Australian children.  Many children with egg allergy can tolerate baked products, but will fail an oral challenge to raw egg. The primary aim of this study is to determine whether allergy to raw egg is better resolved by regular consumption of baked egg (intervention group, baked egg exposure) compared with the standard practice of an egg free diet (control group, egg avoidance).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Merryn Netting

Address

Women's and Children's Health Research Institute
72 King William St
North Adelaide
South Australia 5006

Country

Australia

Phone

+61 8 8161 7443

Fax

+61 8 8239 0267

[email protected]

Contact person for scientific queries

Name

Merryn Netting

Address

Women's and Children's Health Research Institute
72 King William St
North Adelaide
South Australia 5006

Country

Australia

Phone

+61 8 8161 7443

Fax

+61 8 8239 0267

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Netting M J, Gold M, Quinn P, El-Merhibi, A, Pentt... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Debates in allergy medicine: baked egg and milk do not accelerate tolerance to egg and milk	2016	https://doi.org/10.1186/s40413-015-0090-z
Embase	Randomised controlled trial of a baked egg intervention in young children allergic to raw egg but not baked egg.	2017	https://dx.doi.org/10.1186/s40413-017-0152-5

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

Trial Review

Documents added manually

Documents added automatically