FortiColos aims to investigate the safety, tolerability and health effects of bovine colostrum used of human milk fortifier in very preterm infants. The project is the first Danish follow up study after PreColos.
Research on the safety, tolerability and preliminary effects of bovine colostrum for preterm infants
FortiColos is the first large Danish clinical study on bovine colostrum for preterm infants. The main objective is to investigate the safety, tolerability and the preliminary effects of bovine colostrum used as fortifier for mother’s own milk and donor milk in very preterm infants. The study involved two groups of patients. The control group receives the commonly used treatment with infant formula as fortifier to human donor milk, while the intervention group receives bovine colostrum as fortifier to human donor milk.
FortiColos began in December 2017 and the clinical trials are expected to be completed in December 2019. The expected enrollment is 200 preterm infants on five Danish hospitals.The study is based the results obtained from NEOMUNE: the numerous studies on animal models and the confirmation of the feasibility of bovine colostrum as diet supplement for preterm infants in the study PreColos.
Parallel to FortiColos in Denmark, the project PreColos-RCT is running in China using bovine colostrum as diet supplement for the mother’s own milk. The projects highlight different important aspects of how to optimize the clinical care of preterm infants with bovine colostrum as diet supplement and/or milk fortifier.
Read more about FortiColos here on ClinicalTrials.gov: NCT03537365.