Not Yet RecruitingNot Applicable

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

60 participantsStarted 2026-06-15

Plain-language summary

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.

Who can participate

Age range22 Weeks – 32 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Gut microbiota composition in preterm infants

Timeframe: 1 year

Trial details

NCT IDNCT07558499

SponsorZekai Tahir Burak Women's Health Research and Education Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-15

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