Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants

Effect of Rectal Administration of Human Milk on Gut Microbiota and Clinical Outcomes in Preterm Infants: A Randomized Controlled Study

This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. In this randomized controlled study, preterm infants will receive either rectal administration of maternal breast milk or normal saline. The primary objective is to compare gut microbiota composition between the two groups. The findings may provide insight into a novel and non-invasive strategy to support microbiota development in preterm infants.

Preterm infants are highly vulnerable to alterations in gut microbiota due to immaturity, delayed enteral feeding, antibiotic exposure, and environmental factors. Early-life dysbiosis has been associated with adverse outcomes including necrotizing enterocolitis, sepsis, and impaired immune development. Strategies to promote healthy microbiota colonization in preterm infants are therefore of significant clinical interest.

Breast milk contains beneficial bacteria, prebiotics, and bioactive components that play a critical role in shaping neonatal gut microbiota. However, in the early postnatal period, especially in very preterm infants, enteral feeding may be limited or delayed. Alternative routes of exposure to breast milk components may offer a potential strategy to influence microbiota development.

This randomized controlled study aims to investigate the effects of rectal administration of maternal breast milk on gut microbiota in preterm infants. Participants will be randomly assigned to receive either rectal maternal breast milk or normal saline. Stool samples will be collected at predefined time points to assess microbiota composition.

The study is designed to explore whether rectal exposure to breast milk can modulate early microbial colonization and provide a feasible, safe, and innovative approach to support gut microbiota development in preterm infants.

Inclusion Criteria:

Preterm infants with a gestational age ≤32 weeks and birth weight ≤1500 g

Infants without meconium passage within the first 48 hours of life

Infants whose parents have provided written informed consent

Exclusion Criteria:

nfants with major congenital anomalies

Infants with gastrointestinal system anomalies

Infants in whom administration of maternal breast milk is contraindicated

Infants whose parents do not provide consent for participation

Infants who die within the first 72 hours of life