MAESTRO Study
Research type
Research Study
Full title
A randomised, double-blind, controlled, parallel-group, multi-country study to investigate the effect of a partially hydrolysed infant formula with added synbiotics on the development of allergic manifestations in infants at high risk of developing allergy
IRAS ID
217944
Contact name
Faisal Siddiq
Contact email
Sponsor organisation
Nutricia Research
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 26 days
Research summary
The World Health Organization (WHO) recommends exclusive breastfeeding for 6 months and continued breastfeeding thereafter alongside with complementary feeding. Breast milk provides the most appropriate source of nutrition during the first period of life as it has a unique composition (contains important substances) to support the development of growth and a healthy immune system of the newborn infant.
Unfortunately, not all mothers are able to breastfeed as long as they would wish, or they choose to breastfeed their child for a shorter period of time. Mothers will then require an infant formula for their child as an additional or further milk alternative. Infants with a family history of allergies are more likely to develop allergies themselves for example asthma, eczema, hay fever, food allergy or anaphylaxis . Other factors such as genetics, the environment and early infant nutrition can also possibly play a role in developing allergies. For infants at risk of developing an allergy, if breast feeding is not possible, special infant formulas are available.
These formulas are often 'hydrolysed' meaning that the cow’s milk protein is broken down into smaller pieces. The smaller pieces of protein may help prevent allergies as the infant’s body is not able to “recognize” the pieces of protein as allergens. The role of hydrolysed formula in allergy prevention in infants with a family history of allergy has been tested in several clinical studies. Some of these studies suggest there may be beneficial effect of hydrolysed formula compared to standard infant formula. Other studies have also shown that beneficial bacteria (probiotics) and food/fibre (prebiotics) combined together (synbiotics) may also help prevent allergies if added to formula milks.
Nutricia Research has developed a new type of formula, containing hydrolysed (broken down) cow's milk protein and synbiotics. The purpose of this study is to investigate whether this new formula may help to reduce the occurrence of allergies in infants with a family history of allergy compared to standard infant formula. This new formula contains partially hydrolysed (broken down) cow’s milk protein and a synbiotics mixture (a mixture of pre and probiotics which are fibre and beneficial bacteria).
Roughly 1700 healthy infants from different countries, around the world, will be invited to take part in this study. Each infant will take part until they are about a year old. They will be able to participate as a purely breast fed, partially breast fed or completely formula fed infant. The last two groups will be randomized to the specialist infant formula with or without the synbiotics.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0123
Date of REC Opinion
23 Jun 2017
REC opinion
Further Information Favourable Opinion