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

Starting soon · Not applicable

Conditions studied: Premature, Gut Microbiota Diversity and Composition, NEC - Necrotizing Enterocolitis

In brief

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.

Key facts

Study ID

NCT07558499

Run by

Zekai Tahir Burak Women's Health Research and Education Hospital

People needed

60

Starts

2026-06-15

Expected to finish

2027-08-15

Last updated by the study team

2026-04-30

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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