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

NCT07558499 — Not applicable, Not yet recruiting, 60 participants, Zekai Tahir Burak Women's Health Research and Education Hospital

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

Registry	NCT07558499, acronym premic
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	60 (Estimated)
Sponsor	Zekai Tahir Burak Women's Health Research and Education Hospital (Other); collaborators: Umraniye Education and Research Hospital, Kocaeli University
Conditions	Premature, Gut Microbiota Diversity and Composition, NEC - Necrotizing Enterocolitis
Interventions	Rectal irrigation with maternal breast milk, Rectal irrigation with salin (Other)
Dates	start 2026-06-15 (estimated), primary completion 2027-06-15 (estimated), completion 2027-08-15 (estimated), first posted 2026-04-30, last updated 2026-04-30

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Rectal irrigation with maternal breast milk	Experimental	Other: Rectal irrigation with maternal breast milk	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. Maternal breast milk will be used for rectal irrigation.
Rectal irrigation with normal saline	Active comparator	Other: 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.

Rectal irrigation with maternal breast milk (Other): 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 (Other): 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.

+Outcome measures

Primary outcomes

Gut microbiota composition in preterm infants [1 year]: Gut microbiota composition will be analyzed using stool samples collected from preterm infants at 7 days and 1 month of life, including assessment of microbial diversity and relative abundance of bacterial taxa, to evaluate differences between study groups.

Secondary outcomes

Time to full enteral feeding [1 year]: Time to achieve full enteral feeding will be defined as the number of days from birth until the infant tolerates full enteral nutrition without the need for parenteral nutrition.
Feeding intolerance [1 year]: Feeding intolerance will be defined as the occurrence of bilious emesis, gastric residuals, visibly bloody stools, abdominal distension or tenderness, abdominal discoloration, gastric residual volume exceeding 50% of the previous feeding volume, emesis occurring three or more times within a 24-hour period, or clinical or radiological evidence of necrotizing enterocolitis (NEC).
Necrotizing enterocolitis [1 year]: Necrotizing enterocolitis will be diagnosed according to modified Bell's criteria stage II or higher.

+Eligibility

Sex: All, ages: 22 Weeks to 32 Weeks

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