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Trial registered on ANZCTR


Trial ID
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] 279886 0
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 285786 0
Condition category
Condition code
Inflammatory and Immune System 285962 285962 0 0
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] 284205 0
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] 286457 0
Raw Egg Challenge
Timepoint [1] 286457 0
At baseline and after 6 months of intervention.
Secondary outcome [1] 295922 0
Blood test to measure immune markers of tolerance development (serum specific IgE, IgG & IgG4, and cellular immune response profiles).
Timepoint [1] 295922 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284653 0
Charities/Societies/Foundations
Name [1] 284653 0
Women's and Children's Hospital Foundation
Address [1] 284653 0
72 King William St
North Adelaide
South Australia 5006
Country [1] 284653 0
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] 283561 0
None
Name [1] 283561 0
Address [1] 283561 0
Country [1] 283561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286648 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 286648 0
72 King William Road
North Adelaide
South Australia 5006
Ethics committee country [1] 286648 0
Australia
Date submitted for ethics approval [1] 286648 0
Approval date [1] 286648 0
21/12/2011
Ethics approval number [1] 286648 0
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 33739 0
Address 33739 0
Country 33739 0
Phone 33739 0
Fax 33739 0
Email 33739 0
Contact person for public queries
Name 16986 0
Merryn Netting
Address 16986 0
Women's and Children's Health Research Institute
72 King William St
North Adelaide
South Australia 5006
Country 16986 0
Australia
Phone 16986 0
+61 8 8161 7443
Fax 16986 0
+61 8 8239 0267
Email 16986 0
merryn.netting@adelaide.edu.au
Contact person for scientific queries
Name 7914 0
Merryn Netting
Address 7914 0
Women's and Children's Health Research Institute
72 King William St
North Adelaide
South Australia 5006
Country 7914 0
Australia
Phone 7914 0
+61 8 8161 7443
Fax 7914 0
+61 8 8239 0267
Email 7914 0
merryn.netting@adelaide.edu.au