Randomised controlled trial of early introduction of allergenic foods to induce tolerance in infants

Guy's and St Thomas' NHS Foundation Trust0 sites2,500 target enrollmentMarch 31, 2009

Overview

2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26943128 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29987321 results 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34877731/ Secondary analysis (added 09/12/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36521802/ Defining the window of opportunity and the target populations to prevent peanut allergy (added 16/12/2022)

Registry

who.int

Start Date

March 31, 2009

End Date

July 31, 2014

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Pregnant mothers attending their 12/20 week ultrasound scans
•2\. Mothers planning on exclusively breast feeding for at least the first 3 months
•3\. Informed consent obtained from parent or guardian

•1\. Significant antenatal anomaly at 20 week ultrasound scan
•2\. Multiple pregnancy
•3\. Significant congenital disease (enteropathy, congenital heart disease, renal disease)
•4\. Premature delivery (less than 37 completed weeks gestation)
•5\. Parents not planning on breast feeding exclusively for at least the first 3 months
•6\. Parents planning on moving away from London before their child is three years of age
•7\. Parents unable to speak and read English
•8\. Unwillingness or inability to comply with study requirements and procedures
•9\. Family intend infant to be on a restricted diet (any of the six intervention foods)