A prospective double blind randomised controlled study to evaluate the immunological benefits and clinical effects of an elimination diet using an amino acid formula (AAF) with an added pre-probiotic blend in infants with Cow's Milk Allergy (CMA).

Danone Research – Centre for Specialised Nutrition0 个研究点目标入组 170 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•1. Infants < 13 months of age i.e. up to and including the day before the infant is 13 months of age;
•2. Infants with a clinical history of reaction and sensitised to cow's milk by either blood CM specific IgE>0.1kU/L and/or Skin Prick Testing (SPT) wheal size >= 3mm before entering the study. The diagnosis of IgE mediated CMA should be confirmed by cow's milk challenge or history of an anaphylaxis reaction;

•1. Infants in non-Asian countries less than 2500 g at birth. Infants in Asian countries less than 2250 g at birth;
•2. Infants less than 37 weeks gestation and requires specific premature formula at the time of study entry;

发起方

Danone Research – Centre for Specialised Nutrition