PRESTO Neo.1.C/E
Research type
Research Study
Full title
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)
IRAS ID
119485
Contact name
Louise Michaelis
Contact email
Sponsor organisation
Danone Research
Research summary
Food allergies affect up to 3% of the population of infants and young children in western countries. Symptoms of food allergy are gastrointestinal (e.g. failure to thrive, vomiting, diarrhoea, reflux), cutaneous (e.g. atopic dermatitis, urtcaria) and respiratory (e.g. asthma, rhinitis) and many infants and children present with multiple symptoms. Food allergic reactions can range from those that are immediate and life-threatening (e.g. anaphylaxis) to reactions with a slower onset. Management of food allergic disease requires avoidance of the offending protein until such a time that tolerance is acquired.
Infants with cow's milk allergy (CMA) cannot tolerate proteins contained in milk, although they are 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 non-allergenic amino acids plus all the other nutrients required to support growth and development.
This study is a randomised controlled study to evaluate whether a new version of an AAF with added pre- and probiotics can strengthen infants/young children's immune system. This study is planned to be performed in approximately 20 study sites across Europe, USA, Thailand and Singapore. A total of 170 infants (<13 months of age e.g. including the day before the infant is 13 months old) with IgE mediated CMA are expected to be included in this study. In the UK there will be approximately four centres and each will recruit a maximum of 20 participants. The duration of the study for each participant will be 12 months on the study formula with a follow up of two years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0125
Date of REC Opinion
18 Jun 2013
REC opinion
Further Information Favourable Opinion