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NCT Number: NCT07558499

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.

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Key information

Conditions

Premature Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Gut Microbiota Diversity and Composition Intestinal Diseases NEC - Necrotizing Enterocolitis Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gut microbiota composition in preterm infants

    Time frame: 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

  1. Time to full enteral feeding

    Time frame: 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.

  2. Feeding intolerance

    Time frame: 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).

  3. Necrotizing enterocolitis

    Time frame: 1 year

    Necrotizing enterocolitis will be diagnosed according to modified Bell's criteria stage II or higher.

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Collaborators

  • Kocaeli University
  • Umraniye Education and Research Hospital

Registry information

Official study title

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

Acronym: premic

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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