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.

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000535976

Acronym

BEAT

Enrollment

332

Registered

2011-05-24

Start date

2011-07-20

Completion date

2014-12-05

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 4 Months

Healthy volunteers

Yes

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.

Exclusion criteria

Evidence of IgE sensitization to egg at age 4 months Unable to complete study requirements Twin

Outcome results