Optimal timing of solid food introduction to infants at high risk of developing allergic disease.

In infants with eczema the commencement of dietary egg intake from 4 months of age will be compared to the commencement age of 8 months on the outcome of egg allergy at 12 months of age.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000415202

Acronym

STAR Trial

Enrollment

Registered

2009-06-05

Start date

2009-07-15

Completion date

2011-09-07

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 months compared to the more common practice of egg avoidance until 8 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 teaspoon of whole egg powder given orally once per day from 4 to 8 months of age. Cooked egg containing foods will be included in the infant's diet orally from 8-12 months (there will be no specified egg dose from 8-12 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)

Eligibility

Sex/Gender

All

Age

0 to 4 Months

Healthy volunteers

Inclusion criteria

Term singleton infants Infants with symptoms of moderate to severe eczema 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 any congenital or acquired disease or developmental disorder likely to affect infant feeding

Outcome results