Human breast milk is the best nutrition for infants. In cases where it is not possible to exclusively breastfeed for 4 – 6 months, infant formula may be the only nutritional option.
Due to strict requirements (e.g. for the EU/US markets) concerning the demonstration of suitability for use, safety and tolerability, innovation in the infant nutrition ingredient area is time-consuming and expensive. Nevertheless, manufacturers are committed to improving their formulas and to mimicking the composition of breastmilk as much as possible.
In order to obtain market authorization for novel foods as ingredients in infant formulas, or for nutrients or additives that are not yet authorized for this target group, clinical studies are mostly required. Conducting a trial with such a vulnerable population is a complex task. Deep expertise and strong well-trained teams are needed.
a&r has recently conducted an international, multicenter, randomized, and stratified clinical trial – including a control and a breastfed group – to evaluate the effect on growth, safety and tolerability of a combination of human milk oligosaccharides.
Several sites in different EU countries enrolled more than 300 newborns which were exclusively fed study formula or mother’s milk. Anthropometric and clinical assessments were performed and diary-based tolerability parameters as well as stool and milk samples collected.
Thanks to carefully selected and proficient investigator sites (including hospitals and a pediatric network), robust logistic setup, and sophisticated data capture/assessment tools, we could successful recruit for and complete the study in spite of Covid-19 pandemic restrictions. For further details on the study, click here. If you would like to know more about our capabilities, get in touch.