Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000535976
Ethics application status
Approved
Date submitted
24/05/2011
Date registered
24/05/2011
Date last updated
2/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
BEAT- Beating Egg allergy trial. The effect of early introduction of egg in the diet of high risk for atopic infants and subsequent egg allergy: A prospective randomised double blind cohort study.
Scientific title
BEAT-The effect of early introduction of egg in the diet of high risk for atopic infants and subsequent egg IgE sensitisation and clinical allergy: A prospective randomised double blind cohort study.
Secondary ID [1] 262248 0
nil
Universal Trial Number (UTN)
U1111-1121-6988
Trial acronym
BEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Egg allergy 267942 0
Condition category
Condition code
Inflammatory and Immune System 268085 268085 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early blinded introduction of daily egg protein at 4-6 months of age (with first weaning food) until 8 months of age as freeze dried egg powder at 0.5g/day Diet otherwise strict avoidance of all egg until 8 months.

Control group-- Daily Placebo rice powder to be mixed with water/breast milk from 4-6 months of age until 8 months .Avoidance of egg in infants diet until 8 months- including cooked and baked egg in custards/biscuits/cakes/other foods. No other foods will be specifically avoided.
Diet normalised with no dietary restrictions from 8 months of age.
Egg powder and placebo to be continued daily (blinded from 8-12 months of age) with normalised diet.
The intervention and placebo are introduced with the first weaning food- which may be rice cereal, apple, pear (or other first food) and not prior to first food introduction. The powder can then be mixed with these foods on a daily basis. Developmental readness for solids requires that the egg powder and placebo are not introduced until the family has introduced first weaning food.
Intervention code [1] 266642 0
Treatment: Other
Comparator / control treatment
placebo- rice powder
Control group
Placebo

Outcomes
Primary outcome [1] 266824 0
IgE sensitisation as measured by skin prick testing to egg at 8 and 12 months af age.
Timepoint [1] 266824 0
8 months and 12 months of age
Secondary outcome [1] 276453 0
Clinical reactivity to egg (IgE mediated)
Timepoint [1] 276453 0
study period
Secondary outcome [2] 276454 0
IgE sensitisation to other common food allergens (peanut, wheat, soy, milk)
Timepoint [2] 276454 0
8 and 12 months of age.
Secondary outcome [3] 276455 0
Development of doctor diagnosed atopic dermatitis
Timepoint [3] 276455 0
8 and 12 months of age.
Secondary outcome [4] 276456 0
Ovalbumin and Ovomucoid specific IgG4/ IgG1,IgE

This examines markers of potential tolerance to egg protein with anticipated high IgG4. Evidence of IgE to ovalbumin rather than ovicmucoid- both egg proteins may be markers of likley egg tolerance or sensitisation.
Timepoint [4] 276456 0
12 months of age

Eligibility
Key inclusion criteria
First degree relative with atopy
<4 months of age

This is the age requirement for recruitment into the study- for the intervention to start at 4-6 months.
Infants can be recruited from birth, but not do not start intervention until they are >4 months old.
Minimum age
0 Months
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Evidence of IgE sensitization to egg at age 4 months
Unable to complete study requirements
Twin

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)
Babies will be randomly allocated in a 1:1 ratio to "Egg" and "Rice" treatments. Treatment allocation will be stratified by gender. Allocation using permuted blocks to maintain treatment balance over time, and blocks will be a random mixture of sizes to assist allocation concealment."
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
20/07/2011
Date of last participant enrolment
Anticipated
Actual
5/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
332
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5385 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 12837 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 267133 0
Charities/Societies/Foundations
Name [1] 267133 0
Ilhan food allergy foundation
Country [1] 267133 0
Australia
Primary sponsor type
Hospital
Name
Children's Hospital Westmead
Address
Hawkesbury Rd,
Westmead
NSW
2145
Country
Australia
Secondary sponsor category [1] 264208 0
University
Name [1] 264208 0
University of Sydney
Address [1] 264208 0
DPCH, University of Sydney
CHW Clinical School
Hawkesbury Rd,
Westmead
NSW
2145
Country [1] 264208 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267121 0
Children's Hospital Westmead Ethics committee
Ethics committee address [1] 267121 0
Children's Hospital Westmead
Hawkesbury Rd,
Westmead
NSW
2145
Ethics committee country [1] 267121 0
Australia
Date submitted for ethics approval [1] 267121 0
Approval date [1] 267121 0
13/01/2011
Ethics approval number [1] 267121 0
HREC/10/chw/4

Summary
Brief summary
The project aims to test the hypothesis that the early introduction of common food allergens in the diet of infants at high risk of food allergy may increase tolerance and decrease IgE mediated allergen sensitisation and clinical food allergy. Specifically we aim to establish whether introduction of egg protein at 4 months of age into the diet of infants at high risk of atopic disease is associated with a decrease in egg sensitisation and clinical egg allergy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32654 0
Prof Dianne E Campbell
Address 32654 0
Department of Allergy and Immunology,
Hawkesbury Rd
Children's Hospital Westmead, Sydney
NSW, 2145
Australia
Country 32654 0
Australia
Phone 32654 0
61298453420
Fax 32654 0
Email 32654 0
[email protected]
Contact person for public queries
Name 15901 0
Professor Dianne Campbell
Address 15901 0
Department of Allergy and Immunology
Childrens hospital Westmead
Hawkesbury Rd,
Westmead
NSW
2145
Country 15901 0
Australia
Phone 15901 0
+6129845 1055
Fax 15901 0
+61298453389
Email 15901 0
[email protected]
Contact person for scientific queries
Name 6829 0
Professor Dianne Campbell
Address 6829 0
Department of Allergy and Immunology
Childrens hospital Westmead
Hawkesbury Rd,
Westmead
NSW
2145
Country 6829 0
Australia
Phone 6829 0
+61298453366
Fax 6829 0
+61298453389
Email 6829 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
Dimensions AIIntroducing Allergenic Foods in Infants2016https://doi.org/10.1056/nejmc1607281
EmbaseA randomized trial of egg introduction from 4 months of age in infants at risk for egg allergy.2017https://dx.doi.org/10.1016/j.jaci.2016.08.035
N.B. These documents automatically identified may not have been verified by the study sponsor.