Observational Study of Human Milk Composition in Lactating Mothers and Their Newborns Over Two Years

What this Trial Is About

Researchers are conducting a longitudinal observational study involving 120 lactating mothers and their newborns to analyze the composition of human milk over different stages of lactation. The study aims to explore variations in milk composition across different milk groups and relate these findings to maternal, perinatal, infant factors, and the infants microbiota. This research is sponsored by Nutricia Research and spans up to two years of follow-up. Participants will be observed without any intervention, with human milk and fecal samples collected at specific time points Day 3 and Weeks 1.5, 4, 10, 26, 52, and 104 postpartum. The study focuses on exploratory outcome parameters related to human milk and fecal composition. Mothers will provide residual milk samples during these intervals, which will be analyzed to understand milk complexity. During the study, participants will provide milk and fecal samples at scheduled postpartum visits. Researchers will assess milk composition and infant microbiota through these samples and evaluate the relation to various maternal and infant characteristics. Mothers will need to have access to a freezer at -18C and use a mobile device for data collection. The total participation duration can be up to two years, allowing detailed monitoring of milk and infant development.

A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk