NCT01735123.

Trial name or title	Early Dietary Intervention and later signs of beta‐cell Autoimmunity (EDIA)
Methods	Randomised controlled trial.
Participants	Inclusion criteria Infants up to 12 months of age. Infant's parents give signed consent to participate and their HLA genotype is eligible. Exclusion criteria Older sibling of the newborn infant included in the study. Multiple gestation. Parents unwilling or unable to feed the infant cow's milk‐based products for any reason (e.g. religious, cultural). Gestational age of newborn infant less than 35 weeks. Inability of the family to take part in the study (e.g. family had no access to the Study Centre or telephone). Newborn infant has a recognisable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc. Infant receiving any infant formula other than study formula or Nutramigen at the delivery hospital. No HLA sample drawn before the age of 8 days.
Interventions	Experimental: extensively hydrolysed casein formula. Experimental: cow's milk‐based infant formula.
Outcomes	Primary outcome measure: intestinal permeability determined at the age of 3, 6, 9 and 12 months with the lactulose/mannitol test. Secondary outcome measure: serum metabolic profile. Serum metabolic profile will be analysed with metabolomics at the age of 3, 6, 9 and 12 months. Other outcome measures: intestinal microbiome.
Starting date	January 2013. Completion date August 2016.
Contact information	Mikael Knip, MD; mikael.knip@helsinki.fi
Notes	ClinicalTrials.gov Identifier: NCT01735123.