2.1. Study Design and Participants
allergic rhinitis/conjunctivitis, Allergy, CMPA, allergy, AD
FOOD ALLERGY, ALLERGY, ALLERGY, ASTHMA
The Allergy Reduction Trial (A.R.T.) is a multicenter, double-blinded, parallel, randomized controlled study assessing differences in the incidence of CMPA and AD in healthy term infants at high risk of developing allergy (infants with a family history of allergy, i.e., past or present asthma, allergic rhinitis/conjunctivitis, AD, food allergy in at least one parent or sibling), as well as differences in growth outcomes within the first six months of life. Participating infants were EBF or randomly allocated to one of the two intervention formulas: (a) a pHF or (b) an SF. These two study formulas produced by FrieslandCampina (Amersfoort, The Netherlands) and provided for free, were similar in macro-nutrients, apart from the protein fraction. In the case of mixed feeding, the required formula intake was at least 40 mL per kg of body weight per day at the age of one month and 60 mL at the age of two months onwards. Allocation to the mixed-feeding group was allowed until the age of 10 weeks.The study was carried out in Bulgaria, Cyprus, and Greece between 2017–2019, and registered in the Netherlands Trial Registry [Identifier: Trial NL6120 (NTR6259)]. Each study center obtained approval from the respective independent ethics committee.