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Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants
Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
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.
Official title: Effect of Rectal Administration of Human Milk on Gut Microbiota and Clinical Outcomes in Preterm Infants: A Randomized Controlled Study
Key Details
Gender
All
Age Range
22 Weeks - 32 Weeks
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-06-15
Completion Date
2027-08-15
Last Updated
2026-04-30
Healthy Volunteers
No
Interventions
Rectal irrigation with maternal breast milk
Maternal breast milk will be used for rectal irrigation . Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.
Rectal irrigation with salin
Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. Normal saline will be used for rectal irrigation as an active comparator.