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

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.

NCT Number	NCT07558499
Lead Sponsor	Zekai Tahir Burak Women's Health Research and Education Hospital Collaborators: Umraniye Education and Research Hospital, Kocaeli University
Conditions	Premature, Gut Microbiota Diversity and Composition, NEC - Necrotizing Enterocolitis
Enrollment	60 participants
Start Date	2026-06-15
Primary Completion	2027-06-15 (estimated)
Study Completion	2027-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-30