New studies – GRANDIOSA

The N4 research group are starting up several new clinical trials in the autumn and winter of 2022.

We plan to provide a brief introduction to each project over the coming months, and will start with ‘Growth, ALlergy and NeuroDevelopment in Infants On hydrolySed formulA’, or GRANDIOSA.

GRANDIOSA is a blinded, placebo-controlled, randomized clinical trial with Magnus Domellöf as principal investigator. It will be conducted at two study sites: Umeå and Malmö. The purpose of the study is to determine the effects of two novel protein hydrolysates on infants’ growth, neurological development, allergies, gastrointestinal symptoms and other health outcomes.

In the study, we will test two new partially hydrolysed infant formulae. The infants in the study who receive infant formula will be randomly assigned to one of three groups. Two of the groups receive the new partially hydrolysed infant formulae that the study intends to investigate and a third group receives a breastmilk substitute that is already available on the market. In order to compare with breastfeeding, a fourth group of children who are exclusively breastfeed will also be included in the study. The children will follow their assigned regimen until they are five months old and there will be regular follow-up of the children until they are one year old.

Previous studies have suggested that certain protein hydrolysates may be effective against allergic symptoms, gastrointestinal problems and may possibly improve neurodevelopment. The European Food Safety Authority (EFSA) requires novel hydrolysates to be studied before introduction on the market.

A total of 312 healthy, term infants will be included in the study, with start of recruitment in September 2022. Infants will be included at 4-8 weeks of age and receive the intervention until 5 months of age. Follow-up is planned up to 3 years of age.

We will collect comprehensive clinical data, as well as biological samples at multiple time points. We will use state-of-the-art methods for studies of the faecal microbiome, proteomics etc. and we are developing novel methods to measure neurodevelopment, which will be presented in more detail in a separate post.