The first large clinical trials on bovine colostrum as diet supplement or fortifier to mother’s own milk and human donor milk is on. PreColos-RCT is the first follow up study after PreColos.
The first large clinical trial on bovine colostrum for preterm infants is on
After the confirmation of the feasibility of bovine colostrum as diet supplement for preterm infants in the feasibility study PreColos, the large follow up project PreColos-RCT has been initiated. This is the first large study in NEOCOL. The main subject is to study the health effects and determine the time to full enteral feeding. The control group receives the present commonly used treatment with infant formula, while the test group receives bovine colostrum as a diet supplement to the mother’s own milk.
The project runs in China and the expected enrollment is more than 350 infants from nine different hospitals. The recruitment opened in July 2017 and the clinical trials end in March 2019.
The initiations of the clinical trials on bovine colostrum as diet supplement or to mother’s own milk for preterm infants is based on the results and experiences obtained from similar clinical trials using animal models in NEOMUNE (read the abstracts from the published papers here). The expectation are to recreate the results obtained in NEOMUNE on preterm piglets, proving the high feasibility of bovine colostrum as diet supplement to mother’s own milk.
Read more about PreColos-RCT here on ClinicalTrials.gov: NCT03085277.