Early regular egg exposure during infancy to prevent egg allergy: a randomised controlled trial.

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000388011

Acronym

STEP Trial

Enrollment

820

Registered

2010-05-13

Start date

2011-01-12

Completion date

2014-11-12

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

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.

Interventions

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).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

4 Months to 7 Months

Healthy volunteers

Yes

Inclusion criteria

Singleton infants born >35 weeks gestation with a birth weight >2000g. Infants with maternal atopy. Both breastfed and formula fed infants.

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

Outcome results