The primary objective of this study is to evaluate development of tolerance to cow’s milk at 12 months of dietary management in infants with IgE mediated CMA on control (Neocate LCP) or test product (Neocate with added pre and probiotics).

The secondary outcomes are as follows:
– To measure the development of tolerance to cow’s milk in early childhood
– To evaluate maturation of the gastrointestinal immune system in IgE-mediated CMA
– To confirm that the test product is effective in the dietary management of CMA
– To evaluate the occurrence of other allergies

Infants aged up to 13 months old with IgE mediated CMA, confirmed by double blind or open milk challenge, were randomised to the test or control group. Infants were given the study formula from randomisation to 12 months, with a follow-up
period until 36 months after randomisation. The intention is to follow up with an allergy questionnaire at 6 years of age.

Lay Summary

Infants with cow’s milk allergy (CMA) are not able to tolerate proteins contained in cow’s milk or standard infant formulas. Infants with CMA are however able to tolerate amino acids which are the ‘building blocks’ of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from amino acids that do not cause allergic reactions. One of these AAFs is called Neocate Infant. It is a special formula for infants with CMA, which provides an infant’s nutritional requirements when the cow’s milk or formula that causes the allergy are removed from the infant’s diet.

The purpose of this study is to find out if a new version of Neocate Infant formula ((with added pre and probiotics) can strengthen infants’/young children’s immune system, helping them to tolerate cow’s milk earlier and also to see if it reduces the number of other allergies that children with CMA may develop.

Summary of Findings

N/A – study ongoing

Guy's & St Thomas' Hospitals NHS Foundation Trust

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)

Principal Investigator(s)

  • : Dr Adam Fox

Type of Study

This multi-centre study is a prospective, double blind, randomised, controlled study in infants with ige-mediated cma



15th July 2014 - 31st December 2020


Project Manager for National Allergy Strategy

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