Study of Donor Human Milk to Support the Gut Microbiome in Full-Term Infants Born by Cesarean Section

What this Trial Is About

Researchers are investigating the effect of donor human milk DHM compared to formula supplementation on the gut microbiome of full-term infants born by caesarean section who require supplementation. The study aims to understand how DHM influences infant gut bacteria, sleep, growth, and maternal outcomes including depression, anger, breastfeeding confidence, and breastfeeding rates. This pilot randomized controlled trial evaluates DHM as a potential alternative to formula in supporting infant health and maternal well-being. Infants in this study will be randomly assigned to receive either donor human milk or formula each time supplementation is needed during the first seven days of life. DHM used is pasteurized and provided through certified milk banks. The intervention period focuses on the early postpartum week when breastfeeding is being established and formula supplementation is most common. The control group will receive standard care with formula supplementation. Participants will be followed with stool sample collections at one week, three months, and six months to assess differences in gut microbiome diversity and composition. Infant growth measurements, sleep patterns, and breastfeeding outcomes will also be monitored at these timepoints. Maternal mental health, including depression and anger, as well as breastfeeding self-efficacy, will be evaluated from birth through six months postpartum. The study is designed to collect comprehensive data on infant and maternal health outcomes related to feeding type over half a year.

DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.